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MK-2870 versus Chemotherapy in Previously Treated or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) with EGFR Mutations or Other Genomic Alterations
EU CTIS ID: 2023-503539-16-00
What this study is testing
1. To compare MK-2870 to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations. 2. To compare MK-2870 to chemotherapy with respect to OS in NSCLC with EGFR mutations.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations
- Have an ECOG performance status of 0 or 1 within 3 days before randomization
- 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
- At least 18 years of age at the time of providing informed consent
- Measurable disease per RECIST 1.1 as assessed by the local site investigator
You likely can't join if
- Has predominantly squamous cell histology NSCLC
- 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
See the full eligibility criteria
Who can join
- Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations
- Have an ECOG performance status of 0 or 1 within 3 days before randomization
- 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
- At least 18 years of age at the time of providing informed consent
- 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
- HIV-infected participants must have well controlled HIV on ART
What rules you out
- Has predominantly squamous cell histology NSCLC
- 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, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization.
- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- Has mixed tumor(s) with small cell elements
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Taiwan
- Thailand
- Philippines
- Brazil
- Turkey
- Canada
- Hong Kong
- Korea, Republic of
- Vietnam
- Mexico
- China
- Japan
- Chile
- United States
- Malaysia
- Australia
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Taiwan; Thailand; Philippines; Brazil; Turkey and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.