The investigators propose to conduct a retrospective study of single agent ceritinib in patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged adenocarcinoma of the lung with the sole purpose of characterizing the genomic landscape before ceritinib and at the time of disease progression.

NCT02554591

Conditions

1. Carcinoma, Non-Small-Cell Lung
2. Non-small Lung Cancer
3. Non-Small Cell Lung Cancer

MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung

HPO:Neoplasm of the lung Non-small cell lung carcinoma

Secondary mutations found included G1202R, F1174C, and F1174V. --- G1202R ---

This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. Lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether a combination of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with ALK positive non-squamous non-small cell lung cancer.

NCT03737994

Conditions

1. Lung Non-S
2. Lung Non-Squamous Non-Small Cell Carcinoma
3. Stage IV Lung Cancer AJCC v8
4. Stage IVA Lung Cancer AJCC v8
5. Stage IVB Lung Cancer AJCC v8

Interventions

1. Drug: Alectinib
2. Drug: Brigatinib
3. Drug: Carboplatin
4. Drug: Ceritinib
5. Drug: Cisplatin
6. Drug: Crizotinib
7. Drug: Ensartinib
8. Drug: Lorlatinib
9. Drug: Pemetrexed

MeSH:Lung Neoplasms

HPO:Neoplasm of the lung

OUTLINE: Patients with a G1202R or G1202del mutation receive either lorlatinib orally (PO) once daily (QD) or brigatinib PO QD. --- G1202R ---

This study will evaluate the efficacy and safety of alectinib in patients with Anaplastic Lymphoma Kinase (ALK)-positive locally-advanced or metastatic solid tumors other than lung cancer and Cancer of Unknown Primary (CUP).

NCT04644315

Conditions

1. Solid Tumors

Interventions

1. Drug: Alectinib

MeSH:Neoplasms

HPO:Neoplasm

Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) of tumor tissue or peripheral blood - No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant - Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade G1202R, V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) infection - Patients with symptomatic bradycardia - Patients with symptomatic or unstable brain metastasis; patients with primary CNS tumors are allowed - Malabsorption syndrome or any other condition that would interfere with enteral absorption - Incomplete recovery from any surgery prior to treatment - Any other malignancies within 5 years prior to enrollment, except those described in the protocol - Any serious medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study - History of hypersensitivity to any of the ingredients in the alectinib drug formulation Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) of tumor tissue or peripheral blood - No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant - Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade G1202R, V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) infection - Patients with symptomatic bradycardia - Patients with symptomatic or unstable brain metastasis; patients with primary CNS tumors are allowed - Malabsorption syndrome or any other condition that would interfere with enteral absorption - Incomplete recovery from any surgery prior to treatment - Any other malignancies within 5 years prior to enrollment, except those described in the protocol - Any serious medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study - History of hypersensitivity to any of the ingredients in the alectinib drug formulation Solid Tumors Neoplasms null --- G1202R ---

Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) of tumor tissue or peripheral blood - No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant - Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade G1202R, V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) infection - Patients with symptomatic bradycardia - Patients with symptomatic or unstable brain metastasis; patients with primary CNS tumors are allowed - Malabsorption syndrome or any other condition that would interfere with enteral absorption - Incomplete recovery from any surgery prior to treatment - Any other malignancies within 5 years prior to enrollment, except those described in the protocol - Any serious medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study - History of hypersensitivity to any of the ingredients in the alectinib drug formulation Inclusion Criteria: - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer and cancer of unknown primary origin (CUP) - ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) of tumor tissue or peripheral blood - No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant - Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade G1202R, V1180L - Prior therapy with an ALK inhibitor - Liver disease as described in the protocol - Known HIV, hepatitis B, or hepatitis C (HCV) infection - Patients with symptomatic bradycardia - Patients with symptomatic or unstable brain metastasis; patients with primary CNS tumors are allowed - Malabsorption syndrome or any other condition that would interfere with enteral absorption - Incomplete recovery from any surgery prior to treatment - Any other malignancies within 5 years prior to enrollment, except those described in the protocol - Any serious medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study - History of hypersensitivity to any of the ingredients in the alectinib drug formulation Solid Tumors Neoplasms null --- G1202R --- --- V1180L --- --- G1202R ---

This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib

NCT03178071

Conditions

1. Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

Interventions

1. Drug: Lorlatinib

MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung

HPO:Neoplasm of the lung Non-small cell lung carcinoma

For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required. --- G1202R ---