Lung Cancer Clinical Trial

MK-2870 Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Summary

The purpose of this study is to evaluate MK-2870 versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that MK-2870 is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

View Eligibility Criteria

Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
Measurable disease per RECIST 1.1 as assessed by the local site investigator.
Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Have an ECOG performance status of 0 or 1 within 3 days before randomization.

Exclusion Criteria:

Has predominantly squamous cell histology NSCLC.
Has mixed tumor(s) with small cell elements.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
Received prior treatment with a topoisomerase I-containing ADC.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Active infection requiring systemic therapy.
History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

556

Study ID:

NCT06074588

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 32 Locations for this study

See Locations Near You

Mid Florida Hematology and Oncology Center ( Site 0005)
Orange City Florida, 32763, United States More Info
Study Coordinator
Contact
407-353-1915
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
Marietta Georgia, 30060, United States More Info
Study Coordinator
Contact
770-281-5100
Hattiesburg Clinic Hematology/Oncology ( Site 0010)
Hattiesburg Mississippi, 39401, United States More Info
Study Coordinator
Contact
601-261-1700
Capital Health Medical Center - Hopewell ( Site 0006)
Pennington New Jersey, 08534, United States More Info
Study Coordinator
Contact
609-303-0747
Westmead Hospital-Department of Medical Oncology ( Site 3000)
Westmead New South Wales, 2145, Australia More Info
Study Coordinator
Contact
61403170371
Monash Health-Oncology Research ( Site 3001)
Clayton Victoria, 3168, Australia More Info
Study Coordinator
Contact
0421450499
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003)
Melbourne Victoria, 3021, Australia More Info
Study Coordinator
Contact
041554497
Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
Talca Maule, 34655, Chile More Info
Study Coordinator
Contact
56981340385
Orlandi Oncologia-Oncology ( Site 0504)
Santiago Region M. De Santiago, 75007, Chile More Info
Study Coordinator
Contact
56992214787
FALP-UIDO ( Site 0509)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
56224457254
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0502)
Santiago Region M. De Santiago, 83300, Chile More Info
Study Coordinator
Contact
+56963413803
Bradfordhill-Clinical Area ( Site 0507)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56998744662
ONCOCENTRO APYS-ACEREY ( Site 0500)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56992369820
Hong Kong Integrated Oncology Centre ( Site 3200)
Central , 0000, Hong Kong More Info
Study Coordinator
Contact
85237006888
Queen Mary Hospital ( Site 3203)
Hksar , , Hong Kong More Info
Study Coordinator
Contact
39103339
Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204)
Kowloon , 99907, Hong Kong More Info
Study Coordinator
Contact
+85235066255
Princess Margaret Hospital-Department of Oncology ( Site 3201)
Lai Chi Kok , 55555, Hong Kong More Info
Study Coordinator
Contact
85229902803
Rambam Health Care Campus-Oncology Division ( Site 1702)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
04-777-6700
Shaare Zedek Medical Center ( Site 1700)
Jerusalem , 91031, Israel More Info
Study Coordinator
Contact
+972587040620
Rabin Medical Center ( Site 1703)
Petah Tikva , 49414, Israel More Info
Study Coordinator
Contact
054-2531539
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807)
Hwasun Jeonranamdo, 58128, Korea, Republic of More Info
Study Coordinator
Contact
82 10 3635 2876
Asan Medical Center ( Site 3801)
Seoul , 05505, Korea, Republic of More Info
Study Coordinator
Contact
821097929607
Changhua Christian Hospital ( Site 3908)
Changhua County Changhua, 50006, Taiwan More Info
Study Coordinator
Contact
886472385957791
Chang Gung Memorial Hospital at Kaohsiung ( Site 3906)
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan More Info
Study Coordinator
Contact
88677317123
Chi Mei Medical Center ( Site 3910)
Tainan City Tainan, 71004, Taiwan More Info
Study Coordinator
Contact
886-6-2812811
National Taiwan University Cancer Center (NTUCC) ( Site 3903)
Taipei City Taipei, 106, Taiwan More Info
Study Coordinator
Contact
88622312345667511
National Taiwan University Hospital - Hsinchu branch ( Site 3907)
Hsinchu , 300, Taiwan More Info
Study Coordinator
Contact
886223368239
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912)
Kaohsiung , 807, Taiwan More Info
Study Coordinator
Contact
886-7-3121101 ext5651
E-Da hospital ( Site 3911)
Kaohsiung , 82445, Taiwan More Info
Study Coordinator
Contact
+88676150011 ext. 5056
National Cheng Kung University Hospital ( Site 3909)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
National Taiwan University Hospital-Oncology ( Site 3904)
Taipei , 10022, Taiwan More Info
Study Coordinator
Contact
88622312345667511
Mackay Memorial Hospital-Chest Medicine ( Site 3902)
Taipei , 10449, Taiwan More Info
Study Coordinator
Contact
8862254335352854
Taipei Medical University Hospital ( Site 3900)
Taipei , 11030, Taiwan More Info
Study Coordinator
Contact
886227372181-3599

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

556

Study ID:

NCT06074588

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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