Last reviewed · How we verify
NCT05078931
A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients
Active, enrolled
Phase 2
Last updated 30 July 2025
What this trial tests
Phase 2 trial testing Pembrolizumab in NSCLC in 35 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
27 October 2021
Primary endpoint
30 December 2025
30 December 2025
30 December 2026
Quick facts
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 27 October 2021 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
- Lenvatinib (LENVATINIB) — full drug profile →
Conditions studied
- NSCLC — all drugs for NSCLC →
Sponsor
Shanghai Chest Hospital
Who can join
18 and older, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898 -
Immune checkpoint inhibitors for PD-1/PD-L1 axis in combination with other immunotherapies and targeted therapies for non-small cell lung cancer.
Mussafi O, Mei J, Mao W, Wan Y. · · 2022 · cited 12× · PMID 36059606 · DOI 10.3389/fonc.2022.948405 -
Emerging therapeutic strategies for enhancing sensitivity and countering resistance to programmed cell death protein 1 or programmed death-ligand 1 inhibitors in non-small cell lung cancer.
Villaruz LC, Blumenschein GR, Otterson GA, Leal TA. · · 2023 · cited 10× · PMID 36848319 · DOI 10.1002/cncr.34683 -
Revolutionizing NSCLC Treatment: Immunotherapy Strategies for EGFR-TKIs Resistance.
Tian J, Shi Z, Zhao L, Liu P, et al · · 2024 · cited 2× · PMID 39631794 · DOI 10.1111/crj.70037
Verify or expand the search:
- PubMed search for NCT05078931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Chest Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05078931 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Chest Hospital
- Last refreshed: 30 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05078931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing