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NCT05617313
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
Phase 2 trial testing Pembrolizumab in Non Small Cell Lung Cancer in 21 participants. Terminated before completion.
26 June 2025
Quick facts
| Lead sponsor | Jeffrey Clarke |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 17 February 2023 |
| Primary completion | 26 June 2025 |
| Estimated completion | 26 June 2025 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
- GT103 — full drug profile →
Conditions studied
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
- Metastatic NSCLC — all drugs for Metastatic NSCLC →
- Recurrent Non Small Cell Lung Cancer — all drugs for Recurrent Non Small Cell Lung Cancer →
Sponsor
Jeffrey Clarke — full company profile →
Who can join
18 and older, any sex, with Non Small Cell Lung Cancer or Metastatic NSCLC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This open-label, non-randomized Phase II trial is designed to assess the safety and tolerability of GT103 in combination with pembrolizumab in adult subjects with relapsed or refractory, metastatic NSCLC. The study will consist of a safety lead-in of 10-20 patients. A total of 50 patients will be treated with the combination at the safest dose of GT103 as determined in the safety lead-in. If 10 additional patients are enrolled to the dose level -1 then the maximum of 60 subjects may be accrued to this trial.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Humoral complementomics - exploration of noninvasive complement biomarkers as predictors of renal cancer progression.
Revel M, Rezola Artero M, Hamidi H, Grunenwald A, et al · · 2024 · cited 25× · PMID 38487624 · DOI 10.1080/2162402x.2024.2328433 -
Complement factor H targeting antibody GT103 in refractory non-small cell lung cancer: a phase 1b dose escalation trial.
Clarke JM, Simon GR, Mamdani H, Gu L, et al · · 2025 · cited 11× · PMID 39747856 · DOI 10.1038/s41467-024-55092-2 -
A tumor-binding antibody with cross-reactivity to viral antigens.
Campa MJ, Gottlin EB, Wiehe K, Patz EF. · · 2025 · cited 5× · PMID 40009215 · DOI 10.1007/s00262-025-03975-8 -
Emerging Immunotherapies for Advanced Non-Small-Cell Lung Cancer.
Wolf E, Sacchi de Camargo Correia G, Li S, Zhao Y, et al · · 2025 · cited 5× · PMID 40006675 · DOI 10.3390/vaccines13020128
Verify or expand the search:
- PubMed search for NCT05617313
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Non Small Cell Lung Cancer
Currently open trials in the same condition.
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- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
- NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
- NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
Other Jeffrey Clarke trials
Trials by the same sponsor.
- NCT04610684 — Chemotherapy and Atezolizumab for Patients With Extensive Stage Small Cell Lung Cancer (SCLC) With Untreated, Asymptomat · Phase 2 · terminated
- NCT03573947 — Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05617313 (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 Jeffrey Clarke
- 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/NCT05617313.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing