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D002289: Carcinoma, Non-Small-Cell Lung

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (23)


Name (Synonyms) Correlation
drug3346 TBD Compound 3 Wiki 0.45
drug2388 PF-07104091 monotherapy Wiki 0.45
drug876 Continuation of ACEi/ARB Wiki 0.45
Name (Synonyms) Correlation
drug4114 standard chemotherapy Wiki 0.45
drug872 Conjunctival swab and nasopharyngeal swab Wiki 0.45
drug3782 anti-CD40 antibody (CDX-1140) Wiki 0.45
drug2483 Phone Administration of Questionnaires Wiki 0.45
drug873 Connected devices measurements Wiki 0.45
drug2386 PF-07104091 + palbociclib Wiki 0.45
drug1072 Discontinuation of ACEi/ARB Wiki 0.45
drug2854 Remain COVID Free SSI Wiki 0.45
drug134 AZD1390 Wiki 0.45
drug875 Contain COVID Anxiety SSI Wiki 0.45
drug3345 TBD Compound 2 Wiki 0.45
drug2387 PF-07104091 + palbociclib + letrozole Wiki 0.45
drug3564 UCPVax + Nivolumab Wiki 0.45
drug2983 SBRT Wiki 0.45
drug2304 Olaparib Oral Tablet [Lynparza] Wiki 0.45
drug3344 TBD Compound 1 Wiki 0.45
drug869 Computerized Talking Touchscreen Wiki 0.45
drug1281 FLT3 Ligand (CDX-301) Wiki 0.45
drug3738 YH25448 Wiki 0.45
drug2798 Radiotherapy Wiki 0.32

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D008175 Lung Neoplasms NIH 0.57
D055752 Small Cell Lung Carcinoma NIH 0.32
D010051 Ovarian Neoplasms NIH 0.26
Name (Synonyms) Correlation
D064726 Triple Negative Breast Neoplasms NIH 0.26

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0030358 Non-small cell lung carcinoma HPO 0.77
HP:0100526 Neoplasm of the lung HPO 0.34

Clinical Trials

Navigate: Correlations   HPO

There are 5 clinical trials


1 A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of YH25448 when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).

NCT04075396
Conditions
  1. Carcinoma, Non-Small-Cell Lung
Interventions
  1. Drug: YH25448
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

Primary Outcomes

Description: An adverse event is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Measure: Part D: Number of Participants with Adverse Event as a Measure of Safety and Tolerability

Time: Up to 2 years

Description: Plasma Concentration of YH25448 after administration of single dose will be evaluated.

Measure: Part D: Plasma Concentration of YH25448 After Administration of Single Dose (SD)

Time: Up to 2 years

Description: Plasma Concentration of YH25448 after administration of multiple dose will be evaluated.

Measure: Part D: Plasma Concentration of YH25448 After Administration of Multiple Dose (MD)

Time: Up to 2 years

Secondary Outcomes

Description: Plasma Concentration of YH25448 metabolites (M6 and M7) after administration of single and multiple dose will be evaluated.

Measure: Part D: Plasma Concentration of YH25448 Metabolites (M6 and M7) After Administration of Single and Multiple Dose

Time: Up to 2 years

Description: ORR is defined as the percentage of participants who have at least one confirmed Partial response (PR) or Complete response (CR) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) prior to disease progression or recurrence. CR is defined when all target lesions (TLs) and non-target lesions (NTLs) present at baseline have disappeared (with the exception of lymph nodes which must be less than (<)10 millimeters (mm) to be considered non-pathological) and no new lesions have developed since baseline. PR is defined when the sum of diameters of the TLs has decreased by 30 percent (%) or more compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions.

Measure: Part D: Overall Response Rate (ORR)

Time: Up to 2 years

Description: DoR is defined as the time from the date of first documented responses until date of documented progression or death whichever comes first.

Measure: Part D: Duration of Response (DoR)

Time: Up to 2 years

Description: DCR is defined as the percentage of participants with a best overall, extracranial and intracranial response of CR, PR or Stable Disease (SD). CR is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. PR is defined as At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm for extracranial and intracranial lesion, respectively.

Measure: Part D: Disease Control Rate (DCR)

Time: Up to 2 years

Description: Tumor shrinkage is measured at each visit by the percentage change in the sum of the diameters of target lesions compared to baseline measured as greater than or equal to (>=) 10 mm in the longest lesion diameter with computed tomography (CT) or magnetic resonance imaging (MRI).

Measure: Part D: Tumor Shrinkage

Time: Up to 2 years

Description: PFS is defined as the time from first dosing date until documented disease progression or death from any cause whichever occur first based on investigator assessment using RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm for extracranial and intracranial lesion, respectively.

Measure: Part D: Progression Free Survival (PFS)

Time: Up to 2 years

Description: OS is defined as the interval between the date of first dose and the date of participants death due to any cause.

Measure: Part D: Overall Survival (OS)

Time: Up to 2 years
2 Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial

Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide. The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches. The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients. Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

NCT04263051
Conditions
  1. Advanced Non-small Cell Lung Cancer
Interventions
  1. Drug: UCPVax + Nivolumab
  2. Drug: standard chemotherapy
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

Primary Outcomes

Description: PFS is defined by the duration from the date of initiation of the treatment to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment.

Measure: 6 months Progression-Free Survival (PFS) rate

Time: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)
3 FLT3 Ligand (CDX-301), CD40 Agonist Antibody (CDX-1140), and Stereotactic Radiotherapy Versus Standard Therapy for Advanced Non-small Cell Lung Cancer: A Phase I/II Randomized Trial

The purpose of this study is to test a new way of treating the most common form of lung cancer. The investigators are testing a combination of radiotherapy with two new forms of immunotherapy. This study is testing the safety and effectiveness of this treatment approach as compared to standard treatment options.

NCT04491084
Conditions
  1. Non Small Cell Lung Cancer
  2. Lung Cancer
Interventions
  1. Drug: FLT3 Ligand (CDX-301)
  2. Biological: anti-CD40 antibody (CDX-1140)
  3. Radiation: SBRT
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

Primary Outcomes

Description: Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4

Measure: Phase I: Dose-limiting toxicity (DLT), defined as follows:

Time: up to 8 weeks after initiation of study therapy

Measure: Phase II: Progression-free survival (PFS) duration

Time: defined as time from study registration until disease progression (scored using iRECIST) or death, whichever comes first up to 51 weeks.

Secondary Outcomes

Description: Length of time that patient survives from time of study registration

Measure: Overall survival (OS) duration

Time: From date of registration until the date of death from any cause, assessed up to 2 years

Description: The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.

Measure: Radiographic responses using descriptive statistics

Time: From date of registration, assessed up to 4 months

Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning

Measure: Quality of Life using EORTC QLQ-LC13 (quality of Life Questionnaire, Lung Cancer)

Time: 1 year

Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning.

Measure: Quality of Life using QLQ-C30 (Quality of Life Questionnaire)

Time: 1 year

Description: Average daily step counts

Measure: Daily step count using descriptive statistics

Time: 1 year
4 A Platform Study of DNA Damage Response Inhibitors in Combination With Conventional Radiotherapy in Non Small Cell Lung Cancer

CONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB/IIIA/IIIB NSCLC. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.

NCT04550104
Conditions
  1. Non Small Cell Lung Cancer
Interventions
  1. Radiation: Radiotherapy
  2. Drug: Olaparib Oral Tablet [Lynparza]
  3. Drug: AZD1390
  4. Drug: TBD Compound 1
  5. Drug: TBD Compound 2
  6. Drug: TBD Compound 3
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

Primary Outcomes

Description: Dose-limiting toxicities (DLTs), within 13.5 months of starting radiotherapy, in order to establish the Recommended Phase II Dose (RP2D) of each DDRi-RT combination.

Measure: Dose limiting Toxicities

Time: 13.5 months after start of radiotherapy

Secondary Outcomes

Description: Safety will be reported based on the occurrence of SAEs, SARs and SUSARs. Toxicity will be reported based on adverse events, as graded by CTCAE V5.0, and determined by routine clinical assessments at each centre.

Measure: Safety and toxicity

Time: 2 years after end of RT

Description: Treatment compliance will be measured by overall radiotherapy treatment time and delays, omissions and reductions to treatment doses (both DDRi and RT).

Measure: Treatment compliance

Time: End of trial treatment (DDRi and RT)

Description: Best overall response will be measured as the best response (complete response, partial response or stable disease) recorded until disease progression, reported up to 2 years post-RT. This will be assessed using RECIST 1.1

Measure: Best overall response

Time: 2 years after end of RT

Description: This will be assessed using the Green Criteria. Disease Control includes either the complete disappearance of all evidence of malignant disease or residual radiographic abnormalities assessed by chest CT scan at 3 and 6 months after completion of RT, which then remains stable for an additional 6 months or more and which then qualifies as controlled local disease.

Measure: Disease control

Time: 2 years after end of RT

Description: Participants who have not progressed at the time of analysis will be censored at the last date they were known to be alive and progression free

Measure: Progression-free survival

Time: 2 years post-RT

Description: Participants who have not died at the time of analysis will be censored at the last date they were known to be alive

Measure: Overall survival

Time: 2 years post-RT

Description: Health Related Quality of Life will be determined using EORTC QLQ-C30, IL-73 and IL-74

Measure: Changes in Health Related Quality of Life

Time: 2 years after end of RT

Description: Objective response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy. The proportion of patients with evaluable scans that achieve at least a partial response, as defined by RECIST v1.1(31), will be presented with 95% confidence intervals.

Measure: Objective response rate

Time: 2 years after end of RT

Measure: Changes in tumour size during and following treatment with DDRi-RT compared to RT alone.

Time: 2 years after end of RT

Other Outcomes

Description: Exploratory endpoint

Measure: Assessment of mutations in components of DDR pathway in archival tumour and cfDNA prior to therapy

Time: 2 years after end of RT

Description: Exploratory endpoint

Measure: Assessment of T cells within the archival tumour specimens

Time: 2 years after end of RT

Description: Exploratory endpoint

Measure: Changes in cfDNA during and following treatment with DDRi-RT compared to RT alone.

Time: 2 years after end of RT

Description: Exploratory endpoint

Measure: Changes in circulating biomarkers of cardiac and respiratory toxicity during and following treatment with DDRi-RT compared to RT alone.

Time: 3 months post end of RT

Description: Exploratory endpoint

Measure: Changes in circulating peripheral T cell sub-sets during and following treatment with DDRi-RT compared to RT alone.

Time: 2 years after end of RT

Description: Exploratory endpoint

Measure: Changes in lung parenchyma during and following treatment with DDRi-RT compared to RT alone.

Time: 2 years after end of RT
5 PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.

NCT04553133
Conditions
  1. Small Cell Lung Cancer
  2. Ovarian Cancer
  3. Triple Negative Breast Cancer
  4. Non-small Cell Lung Cancer
  5. Human Receptor-positive Human Epidermal Growth Factor Receptor 2
Interventions
  1. Drug: PF-07104091 monotherapy
  2. Drug: PF-07104091 + palbociclib
  3. Drug: PF-07104091 + palbociclib + letrozole
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Small Cell Lung Carcinoma Triple Negative Breast Neoplasms
HPO:Neoplasm of the lung Non-small cell lung carcinoma Ovarian neoplasm Small cell lung carcinoma

Primary Outcomes

Description: Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level

Measure: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

Time: 28 days

Description: Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level

Measure: To evaluate incidence of treatment emergent adverse events and laboratory abnormalities

Time: From baseline until end of study treatment or study completion (approximately 2 years)

Description: Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level

Measure: Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline

Time: From baseline until end of study treatment or study completion (approximately 2 years)

Description: Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level

Measure: Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline

Time: From baseline until end of study treatment or study completion (approximately 2 years)

Description: Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level

Measure: To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline

Time: From baseline until end of study treatment or study completion (approximately 2 years)

Description: Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1

Measure: To evaluate the preliminary antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose expansion

Time: From baseline through disease progression or study completion (approximately 2 years)

Secondary Outcomes

Description: Peak concentration of PF-07104091 during selected cycles

Measure: Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose

Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

Description: Time to peak concentration of PF-07104091 during selected cycles

Measure: Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose

Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

Description: AUC of PF-07104091 will be calculated at selected cycles

Measure: Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091

Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

Description: AUC of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food

Measure: Area under the curve of PF-07104091 with or without food

Time: From baseline through time to event on study or study completion (approximately 2 years)

Description: Peak concentrations of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food

Measure: Maximum plasma concentration of PF-07104091 with or without food

Time: From baseline through time to event on study or study completion (approximately 2 years)

Description: Percentage of participants with a best overall response of CR or PR using RECIST 1.1

Measure: To document any preliminary evidence of antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose escalation

Time: From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)

Description: Time from first assessment of event endpoint to last assessment of using RECIST 1.1

Measure: To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints

Time: From baseline through time to event on study or study completion (approximately 2 years)

HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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