Lenvatinib in Combination With Carboplatin Pemetrexed and Pembrolizumab for NSCLC With EGFR Mutat… (NCT05258279) | Clinical Trial Compass
CompletedPhase 2
Lenvatinib in Combination With Carboplatin Pemetrexed and Pembrolizumab for NSCLC With EGFR Mutations
Japan30 participantsStarted 2022-07-01
Plain-language summary
The purpose of this study is to assess the safety and efficacy of pemetrexed + carboplatin + pembrolizumab (MK-3475) with lenvatinib (MK-7902/E7080) in patients with advanced nonsquamous non-small cell lung cancer harboring EGFR mutations.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have a histologically or cytologically confirmed diagnosis of incurable Stage IIIB, IIIC, IVA, IVB (American Joint Committee on Cancer \[AJCC\], version 8) non-squamous NSCLC. Postoperative recurrence is acceptable if the disease is not curable.
. Have documentation of tumor activating EGFR mutation, specifically either exon 19 deletion or exon 21 L858R.
. Have investigator determined radiographic disease progression per RECIST 1.1 after treatment with EGFR-TKI therapy:
. Participants previously treated with 1st or 2nd generation EGFR TKI (eg, erlotinib/afatinib/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation.
. Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR-TKI (eg, erlotinib/afatinib/gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined four treatments — lenvatinib, carboplatin, pemetrexed, and pembrolizumab — for EGFR-mutated non-squamous NSCLC. Given that's a lot of drugs at once, what kinds of side effects or safety concerns showed up, and how would those risks compare to what I'd face with standard first-line treatment for my specific EGFR mutation?
2Since this was a Phase 2 trial, the main goal was measuring how many patients' tumors responded — the objective response rate — rather than long-term survival. Does that mean we still don't know much about whether this approach actually helps people live longer, and should that affect how I weigh it against proven options?
3This trial is now completed, so results may be available — have you seen any published data from it, and based on those findings, do you think this combination is something worth pursuing for my case or does the evidence still point toward other approaches?
4My tumor has an EGFR activating mutation, and there are already approved targeted therapies like osimertinib designed specifically for that. Would it be worth discussing those targeted options first before considering a chemotherapy-immunotherapy combination like the one tested in this trial?
5Since I have an EGFR mutation, I've read that immunotherapy like pembrolizumab sometimes works differently in patients like me — is that something the trial accounted for, and is it a factor we should talk through when deciding whether this combination makes sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR) as Assessed by BICR according to RECIST 1.1
. Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status.
. Participants treated with a combination of EGFR TKIs and antibodies targeting the VEGF pathway will also be eligible.
. Have measurable disease per RECIST 1.1.
Exclusion criteria
. Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, clinically stable, and have not required steroids for at least 14 days prior to the first dose of study intervention.
. Has history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
. Radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered because for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy (in the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta).
. Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease of that disease recurrence for at least 3 year since initiation of that therapy.
. Has an autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
. Has had an allogeneic tissue/solid organ transplant.
. Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.