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Biomarker-Driven Therapy and Immunotherapy in Screening Participants with Recurrent or Stage IV Non-Small Cell Lung Cancer (The Expanded Lung-MAP Screening Trial)


Active: Yes
Cancer Type: Lung Cancer NCT ID: NCT03851445
Trial Phases: Phase II
Phase III
Protocol IDs: LUNGMAP (primary)
LUNGMAP
NCI-2018-01540
Eligibility: 18 Years and older, Male and Female Study Type: Screening
Study Sponsor: SWOG
NCI Full Details: http://clinicaltrials.gov/show/NCT03851445

Summary

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.

Objectives

PRIMARY OBJECTIVE:
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.

SECONDARY SCREENING SUCCESS RATE OBJECTIVE:
I. To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study.

SECONDARY TRANSLATIONAL MEDICINE OBJECTIVE:
I. To establish a tissue/blood repository.

ANCILLARY STUDY S1400GEN OBJECTIVES (CLOSED TO ACCRUAL 06/30/2019):
PRIMARY OBJECTIVE:
I. To evaluate patient attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.

SECONDARY OBJECTIVES:
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.

OUTLINE:
Participants undergo collection of tumor tissue samples or submit previous genomic profile testing results. 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 30-60 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 non-small cell lung cancer [NSCLC] patients only), or ramucirumab IV over 30-60 minutes combined with docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) scans and collection of blood samples throughout the trial.

ARM B: Patients receive ramucirumab IV over 30-60 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 with pembrolizumab repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI scans and collection of blood samples throughout the trial.

S1800D: Patients are randomized to 1 of 2 arms.

ARM A: Patients may receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1 of each cycle; gemcitabine IV over 30 minutes on days 1 and 8 of each cycle; pemetrexed IV over 10 minutes on day 1 of each cycle; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI and collection of blood samples throughout trial.

ARM B: Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa subcutaneously (SC) on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI and collection of blood samples throughout trial.

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. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

S1900B (CLOSED TO ACCRUAL 5/01/2021) : Patients with RET fusion receive selpercatinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI and undergo blood sample collection throughout the trial.

S1900C (CLOSED TO ACCRUAL 12/18/2020): Patients with STK11 somatic mutation or STK11 bi-allelic loss receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection throughout the trial.

S1900E: Patients with KRAS G12C mutation receive sotorasib PO once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

S1900F: Patients with RET fusion are randomized to 1 of 2 arms.

ARM A: Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also selpercatinib PO BID in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans during screening and on study, and collection of blood samples on study.

ARM B: Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans during screening and on study, and collection of blood samples on study.

S1900K: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive ramucirumab IV over 30-60 minutes on day 1 of each cycle and tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan at screening prior to treatment, at the first occurrence of peripheral edema (defined as the development of grade = 1 Common Terminology Criteria for Adverse Events [CTCAE] Edema Limbs affecting either the arms, hands, or legs), and if peripheral edema increases in attribution. Patients also undergo CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.

ARM B: Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan at screening prior to treatment, at the first occurrence of peripheral edema (defined as the development of grade = 1 CTCAE Edema Limbs affecting either the arms, hands, or legs), and if peripheral edema increases in attribution. Patients also undergo CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.

S1800E: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.

ARM II: Patients receive dexamethasone PO BID on days 0-2, ramucirumab IV over 30-60 minutes on day 1, docetaxel IV over 60 minutes on day 1, and cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, and CT or MRI throughout the study.

ANCILLARY STUDY S1400GEN (OPTIONAL) (CLOSED TO ACCRUAL AS OF 6/30/2019):
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.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta
3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com



Atlanta Cancer Care - Conyers
1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com



Atlanta Cancer Care - Cumming
1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com



Atlanta Cancer Care - Decatur
2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:


Atlanta Cancer Care - Stockbridge
7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com



Atlanta Cancer Care - Tower
5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com



Georgia Cancer Specialists - Athens
125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com



Georgia Cancer Specialists - Canton
228 Riverstone Drive
Canton, GA 30114
www.gacancer.com



Georgia Cancer Specialists - CenterPointe
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com



Georgia Cancer Specialists - Kennestone
790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com



Georgia Cancer Specialists - Macon-Coliseum
308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com



Georgia Cancer Specialists - Stemmer
2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com



Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org



Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com



Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com



Phoebe Cancer Center at Phoebe Putney Memorial Hospital
425 Third Avenue
Albany, GA 31702
229-312-5091
www.phoebehealth.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.