Clinical trial · no report yet · Phase 1/Phase 2
REZILIENT 1
A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer
- NCT04036682 ↗
- Active, not recruiting
- Cullinan Therapeutics Inc.
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 21 | |
| YouTube | 4 | |
| Podcasts | 2 | |
| Bluesky threads | 1 |
The trial
ClinicalTrials.gov- Official title
- A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- Conditions
- Non Small Cell Lung Cancer; EGFR Exon 20 Mutation
- Interventions
- CLN-081
- Arms
- Phase 1 Dose Escalation (Accelerated Titration) · Experimental
- Phase 1 Dose Escalation (Rolling Six) · Experimental
- Phase 2a Dose Expansion(s) · Experimental
- Module A Food Affect · Experimental
- Module B · Experimental
- Module C · Experimental
- Enrollment
- 284 (estimated)
- Primary outcomes
- All Cohorts: The rate and severity of treatment emergent AEs.
- All Cohorts: The rate and severity of DLTs.
- Phase 2 Dose Expansion Cohorts: Overall response rate (ORR)
- Module A: Pharmacokinetic (PK) parameter
- Module A: Pharmacokinetic (PK) parameter
- Module B and C: Confirmed overall response rate (ORR) and duration of response (DOR) by independent review committee (IRC)
- Sponsor
- Cullinan Therapeutics Inc. with Taiho Oncology, Inc.
- Start
- Oct 31, 2019
- Primary completion
- Oct 13, 2025
- Results posted
- No
- Registry record
- NCT04036682 · updated Jun 17, 2026
Publications
linked from the registry- Piotrowska Z, Passaro A, Nguyen D, Ruiter G, Soo RA, Ho-Fun Lee V, Velcheti V, Tan DS, Lee SH, Kim SH, Wrangle J, Yang JC, Daga H, Juan Vidal OJ, Spira AI, Fernandez-Hinojal G, Kim SW, Umemura S, Provencio Pulla M, Keeton EK, Yang ZS, Li S, Xu ZC, Jones JA, Yu HA; REZILIENT1 Investigators. Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab. J Clin Oncol. 2025 Jul 20;43(21):2387-2397. doi: 10.1200/JCO-25-00763. Epub 2025 Jun 1. PubMed 40450572
- Piotrowska Z, Tan DS, Smit EF, Spira AI, Soo RA, Nguyen D, Lee VH, Yang JC, Velcheti V, Wrangle JM, Socinski MA, Koczywas M, Janik JE, Jones J, Yu HA. Safety, Tolerability, and Antitumor Activity of Zipalertinib Among Patients With Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertions. J Clin Oncol. 2023 Sep 10;41(26):4218-4225. doi: 10.1200/JCO.23.00152. Epub 2023 Jun 29. PubMed 37384848
- Ye L, Chen X, Zhou F. EGFR-mutant NSCLC: emerging novel drugs. Curr Opin Oncol. 2021 Jan;33(1):87-94. doi: 10.1097/CCO.0000000000000701. PubMed 33122578