Active — Not RecruitingPhase 2

A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients

China35 participantsStarted 2021-10-27

Plain-language summary

This study will investigate the efficacy and safety of the combination of pembrolizumab and lenvatinib in PD-L1 positive patients with TKI-resistant EGFR-mutated advanced NSCLC.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Have a histologically or cytologically confirmed stage IV NSCLC by American Joint Committee on Cancer Version 8
✓. Have confirmation with sensitizing EGFR mutations, either DEL19 or L858R
✓. Have undergone failure 1-2 prior EGFR-TKI (Osimertinib exposure required for T790M+)
✓. Have measurable disease based on RECIST 1.1, as determined by the local site.
✓. Tumor tissue that demonstrates PD-L1 expression in ≥1% of tumor cells (TPS ≥1%) as assessed by IHC 22C3 pharmDx.

Exclusion criteria

✕. Has known untreated central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 4 weeks by repeat imaging (note: repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days before first dose of study intervention.
✕. Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of study intervention.
✕. Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy.
✕. Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.
✕. Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with the 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 not considered a form of systemic treatment and is allowed.
✕. 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.
✕. Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.

What they're measuring

Progression-free survival

Timeframe: Up to approximately 12 months

Trial details

NCT IDNCT05078931

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

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