A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)
18 Years and older, Male and Female
This expansion of the screening and multi-sub-study Lung-MAP trial is motivated by the changing landscape due to progress in the development of immunotherapies. The Lung-MAP trial was originally opened in June of 2014 for second-line treatment of participants with stage IV squamous lung cancer or squamous lung cancer that has come back (recurrent). The trial was amended to allow all participants with previously-treated stage IV or recurrent squamous lung cancer in 2015. The study is now expanding to allow participants with all types of previously-treated stage IV or recurrent non-small cell lung cancer. The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned in order to compare new targeted cancer therapy designed to block the growth and spread of cancer, with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes “non-match” sub-studies which will include all screened participants not eligible for any of the biomarker-driven sub-studies.
I. To test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.
I. To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study.
II. To evaluate circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening.
III. To establish a tissue/blood repository.
ANCILLARY STUDY S1400GEN OBJECTIVES:
I. To evaluate patient attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.
I. To evaluate Lung-MAP study physician attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.
II. To evaluate Lung-MAP patients’ and study physicians’ knowledge of cancer genomics.
III. To evaluate Lung-MAP patients’ and study physicians’ knowledge of the design of the Lung-MAP Screening Study.
IV. To explore whether physician and patient knowledge of cancer genomics and attitudes and preferences about return of genomic profiling findings are correlated.
Participants undergo collection of tumor tissue samples. Participants are then assigned to a biomarker-driven or non-match sub- study based on biomarker results of tumor tissue samples.
S1800A (NON-MATCH SUB-STUDY): Patients are randomized to 1 of 2 arms.
ARM A: Patients may receive docetaxel intravenously (IV) over 10-30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, pemetrexed IV over 10 minutes on day 1 (non-squamous NSCLC patients only), or ramucirumab IV over 60 minutes combined with docetaxel IV over 10-30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive ramucirumab IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
S1900A: Patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation receive rucaparib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ANCILLARY STUDY S1400GEN (OPTIONAL):
Patients and physicians of patients enrolled to Lung-MAP complete a telephone-based survey over 25-30 minutes (patients) or a web-based survey over 10-15 minutes (physicians) that focuses on knowledge, attitudes, and preferences about genetic findings.
After completion of study intervention, participants are followed up every 6 months for up to 3 years.
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