This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

NCT03373760

Conditions

1. Recurrent Squamous Cell Lung Carcinoma
2. Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions

1. Biological: Durvalumab
2. Other: Laboratory Biomarker Analysis
3. Biological: Tremelimumab

MeSH:Carcinoma Lung Neoplasms

HPO:Carcinoma Neoplasm of the lung

The Brookmeyer-Crowley method will be used to calculate confidence intervals for median OS.. Inclusion Criteria: - Patients must have been assigned to S1400F - Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. --- S1400F ---

post Hashimoto syndrome) who are stable on hormone replacement therapy are eligible - Patients must not have any history of primary immunodeficiency - Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive these medications while on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy - Patients must not have experienced a grade 3 or worse immune-related adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved irAE grade 2, nor have experienced a toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy - Patients must not have any history of organ transplant that requires use of immunosuppressives - Patients must not have any known allergy or reaction to any component of the durvalumab (MEDI4736) and/or tremelimumab formulation - Patients must not have clinical signs or symptoms of active tuberculosis infection - Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration - Patients must not have known human immunodeficiency virus (HIV), or a known positive test for hepatitis B virus surface antigen (HBV sAg), or hepatitis C virus ribonucleic acid (HCV antibody) indicating current acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed - Patients must have a thyroid-stimulating hormone (TSH) with reflex free T3/free T4 (if TSH is out of normal range) and electrocardiogram (EKG) obtained within 7 days prior to sub-study registration - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens Inclusion Criteria: - Patients must have been assigned to S1400F - Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. --- S1400F ---

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

NCT02154490

Conditions

1. Recurrent Squamous Cell Lung Carcinoma
2. Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions

1. Drug: Docetaxel
2. Biological: Durvalumab
3. Drug: Erlotinib Hydrochloride
4. Drug: FGFR Inhibitor AZD4547
5. Biological: Ipilimumab
6. Other: Laboratory Biomarker Analysis
7. Biological: Nivolumab
8. Drug: Palbociclib
9. Other: Pharmacological Study
10. Biological: Rilotumumab
11. Drug: Talazoparib
12. Drug: Taselisib
13. Biological: Tremelimumab

MeSH:Carcinoma Lung Neoplasms

HPO:Carcinoma Neoplasm of the lung

S1400F: Patients with disease progression during or after prior anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment receive durvalumab (IV over 60 minutes) and tremelimumab (IV over 60 minutes) on day 1 for courses 1-4 and durvalumab IV alone on day 1 of course 5 and subsequent courses until disease progression or unacceptable toxicity. --- S1400F ---