Strong Initial Efficacy Data Reported in 3L NSCLC from Ph 2 THIO-101 Part C Expansion Trial July 15, 2026
Results from ELEVATE study of postoperative adjuvant ensartinib in stage IB–IIIB (T3N2M0) ALK-positive NSCLC published in NEJM July 15, 2026
Clinical results of Ph 1b/2 trial of ifebemtinib + garsorasib in 1L KRASG12C-mutant NSCLC published in The Lancet Respiratory Medicine July 15, 2026
Global Data for Pumitamig Shows Encouraging Efficacy in NSCLC Patients in ROSETTA Lung-02 Trial July 15, 2026
Ph 3 AURORA Trial of Aglatimagene Besadenovec (CAN-2409) in Advanced NSCLC Patients with Inadequate Response to Immune Checkpoint Inhibitors initiated July 7, 2026
Divarasib shows superiority in head-to-head Ph 3 trial against sotorasib or adagrasib in NSCLC July 7, 2026
FAILED TRIAL: Ph 3 SigVie-002/Be6A Lung-01 trial of sigvotatug vedotin in 2L+ NSCLC did not show a statistically significant OS improvement vs docetaxel June 30, 2026
Ph 3 DAREON®-Lung-1 in SCLC, DAREON®-NEC-1 in extrapulmonary NEC, and Beamion LUNG-3 trials in HER2-mutant NSCLC initiated June 23, 2026
The third U.S. clinical site in Ph 2 THIO-101 expansion trial of ateganosine enrolling patients in 3L NSCLC June 23, 2026
Second US Clinical Site Activated and Enrollment Opened for International Ph 2 THIO-101 Expansion Trial June 17, 2026
US FDA Fast Track Designation for VS-7375 for the Treatment of KRAS G12D-Mutated Locally Advanced or Metastatic NSCLC June 10, 2026
Trial Discontinuation: External DMC recommends discontinuing Ph 3 KEYNOTE-D46/EVOKE-03 study of Trodelvy + KEYTRUDA in 1L metastatic NSCLC with high PD-L1 expression June 10, 2026
FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026 June 2, 2026
FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084) for Certain Patients with 1L Metastatic KRAS G12C-Mutant NSCLC June 2, 2026
Primary Endpoints Met in Final Analysis of Ph 3 Study for Perioperative Toripalimab plus Chemotherapy for Resectable Stage II-III NSCLC June 2, 2026
Whitehawk Therapeutics Expands ADC Pipeline with New Option Agreement for Use of CPT113 Linker-Payload May 26, 2026
First patient dosed in Spain in Ph 2 HLX43-NSCLC201 trial of HLX43 for the treatment of advanced NSCLC May 26, 2026
Successful Outcome of FDA Type C Meeting Request for HARMONIC Ph 2 Trial of LP-300 in Never-Smokers with NSCLC Announced May 26, 2026
