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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)

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Screening
NCT ID
NCT03851445
Protocol IDs
LUNGMAP (primary)
LUNGMAP
NCI-2018-01540
Study Sponsor
SWOG

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

S1900B: Patients with RET fusion receive selpercatinib PO twice daily BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

S1900C: 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.

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.

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.

Eligibility

  1. REGISTRATION ELIGIBILITY STEP 0
  2. Patients with adequate archival tissue or a qualifying commercial FoundationOne CDx report should be registered directly to Step 1, without registering to Step 0. Patients who will submit tumor tissue from a new biopsy (not archival tissue) must also submit whole blood for ctDNA testing collected within +/- 7 days of the biopsy, preferably the same day. These patients must be registered to Step 0 in OPEN to obtain a patient ID number for the whole blood submission
  3. Patients registered to Step 0 are not registered to the LUNGMAP protocol. To participate in LUNGMAP (including submission of tissue obtained from the new biopsy), patients must be registered to Step 1 in OPEN after evaluation of patient eligibility, including tumor tissue adequacy. The same SWOG patient ID number must be used
  4. REGISTRATION STEP 1
  5. Patients must have pathologically or cytologically proven non-small cell lung cancer (NSCLC; all histologic types). Patients must have stage IV disease, or recurrent/progressive disease without a curative treatment option available. Mixed NSCLC histologies, are acceptable, but any known component of small cell lung cancer is not allowed
  6. Patients must either have progression on prior systemic treatment or have received at least one dose of systemic treatment as defined below. These criteria are: * Screening at progression on prior treatment: To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (stages I-IV) and must have progressed during or following their most recent line of therapy ** For patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 therapy, alone or in combination ** For patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any systemic treatment for stage IV or recurrent/progressive disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy. For patients treated with anti-PD-1 or anti-PD-L1 therapy for stage I-III disease, disease progression on consolidation anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from the date of initiation of such therapy. If disease progression was greater than one year after prior therapy, patients must receive subsequent systemic therapy to be eligible * Pre-Screening prior to progression on current treatment: ** To be eligible for pre-screening, patients must have received at least one dose of a systemic regimen for stage IV or recurrent/progressive disease and must be prior to progression on this regimen ** Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 therapy alone or in combination * NOTE: Patients will not receive their sub-study assignment until they progress and the LUNGMAP Notice of Progression is submitted
  7. Patients must either have adequate tissue available to submit on-study or have a prior known commercial FoundationOne CDx tissue-based (not liquid) tumor test for biomarker profiling. All other previous next-generation DNA sequencing (NGS) results will not be accepted * Submitting tissue for on-study biomarker profiling: Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume ** The local interpreting pathologist must review the specimen ** The pathologist must sign the LUNGMAP Local Pathology Review Form confirming tissue adequacy prior to Step 1 registration Specimens from bone biopsy are not allowed unless the specimen is entirely soft tissue or has not been decalcified. All other sites of tumor are acceptable, given the specimen meets all requirements for tissue adequacy. A formalin-fixed and paraffin-embedded (FFPE) tumor block or unstained FFPE slides 4-5 microns thick must be submitted. If slides are to be submitted, at least 12 unstained slides plus an hematoxylin and eosin (H&E) stained slide, or 13 unstained slides must be submitted. However, if slides are to be submitted, it is strongly recommended that 20 unstained slides be submitted. Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling. If archival tumor material is exhausted, then a new tumor must be obtained. Patients who submit tumor tissue from a new biopsy must also submit whole peripheral blood for ctDNA testing. Patients must agree to have any leftover tissue (tissue that remains after biomarker testing) retained for the use of correlative studies outlined in the sub-study consents OR * Submitting commercial FoundationOne CDx results for reanalysis: Patients must have a FoundationOne CDx report available with the following information: ** Results done on solid tumor tissue (liquid test not allowed) ** Original report date on or after September 1,2019 ** FMI Test Order # (e.g. ORD-1234567) Patients must consent to have their commercial FoundationOne CDx test results disclosed to SWOG Cancer Research Network
  8. Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (CLIA) biomarker profiling and PD-L1. If archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If FFPE slides are to be submitted, at least 12 unstained slides plus an Hematoxylin and eosin (H&E) stained slide, or 13 unstained slides must be submitted. However, it is strongly recommended that 20 FFPE slides be submitted * Note: Previous next-generation DNA sequencing (NGS) will be repeated if done outside this study for sub-study assignment
  9. Patients must agree to have any leftover tissue (tissue that remains after biomarker testing) retained for the use of correlative studies outlined in the sub-study treatment consents
  10. Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have progressed following all appropriate standard of care therapy/therapies (in the investigator’s opinion). EGFR/ALK/ROS1/BRAF testing is not required prior to Step 1 registration, as it is included in the LUNGMAP Foundation Medicine biomarker profiling
  11. Patients’ most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to Step 1 registration
  12. Patients must also be offered participation in banking for future use of specimens
  13. Patients must be willing to provide prior smoking history as required on the LUNGMAP On-study Form
  14. As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  15. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Treatment Sites in Georgia

Atlanta Cancer Care - Conyers


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

Atlanta Cancer Care - Decatur


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

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge


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

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Georgia Cancer Specialists - CenterPointe


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

Doctors:

Rodolfo E. Bordoni MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Macon-Coliseum


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

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