FEB 28 2027
Cullinan Therapeutics — zipalertinib $CGEM
for EGFR exon 20 insertion-positive non-small cell lung cancer
Accepted APR 28 2026.
About
Non-small cell lung cancer is a malignant tumor that originates in lung tissues, where damaged cells multiply uncontrollably and can spread throughout the body if untreated. Zipalertinib is a small molecule that selectively blocks EGFR proteins with exon 20 insertion mutations, which are faulty growth signals driving cancer cell division. By targeting this specific mutation, zipalertinib may slow tumor growth in patients whose cancers are fueled by these abnormal EGFR signals.
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
- Cullinan Therapeutics (CGEM) logs Q1 loss as FDA accepts zipalertinib NDA and cash tops $351.9M - Stock Titan
- FDA Accepts NDA for Zipalertinib in Locally Advanced or Metastatic EGFR Exon 20+ NSCLC - OncLive
- FDA Accepts NDA for Zipalertinib in EGFR Exon 20-Mutant Lung Cancer - Targeted Oncology
- 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
Sponsor Watch — recent news on Cullinan Therapeutics
- 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
- 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
- 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