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
HETRONIFLY (serplulimab) recommended by the NICE for routine use within the NHS in England and Wales 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
FAILED TRIAL: Ph 3 LAGOON trial of Zepzelca in patients with 2L SCLC did not meet primary endpoint of OS 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
FDA Grants Priority Review to Supplemental NDA for HYRNUO® (sevabertinib) Under Investigation in 1L HER2-Mutated NSCLC May 21, 2026
