FEB 28 2027
Cullinan Therapeutics — zipalertinib $CGEM
for EGFR exon 20 insertion-positive non-small cell lung cancer
Accepted APR 28 2026.
About
EGFR exon 20 insertion-positive non-small cell lung cancer is a form of lung cancer where specific genetic damage causes airway cells to multiply uncontrollably, forming tumors that can spread and impair lung function. Zipalertinib is a small molecule drug designed to selectively block the activity of the mutated EGFR protein that drives this uncontrolled growth. By precisely inhibiting this faulty growth signal, zipalertinib could potentially help control the cancer after surgery.
Pivotal trial
The purpose of this study is to compare the efficacy of zipalertinib combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in participants with early stage (stage IB-IIIA) resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on zipalertinib
- FDA Accepts NDA for Zipalertinib in Locally Advanced or Metastatic EGFR Exon 20+ NSCLC - OncLive
- U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations - Business Wire
- FDA sets target date for zipalertinib for advanced lung cancer - Managed Healthcare Executive
- Rolling NDA Submission Completed for Zipalertinib in EGFR+ NSCLC - CancerNetwork
- Taiho, Cullinan file rolling NDA on phase I/II zipalertinib data - BioWorld News
Sponsor Watch — recent news on Cullinan Therapeutics
- Cullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 Congress
- Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia
- Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results
- Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results
- Cullinan Therapeutics Touts 2026 “Defining Year” as T-Cell Engager, Zipalertinib Catalysts Near