Novartis terminates phase III KontRASt-02 trial of JDQ443 in lung cancer

Novartis Pharmaceuticals has terminated its phase III "KontRASt-02" trial evaluating JDQ443 against docetaxel in patients with previously treated, locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer. According to the ClinicalTrials.gov record, the study's status is listed as terminated, with the reason given as business reasons and not based on any safety concerns.¹

The trial began on June 15, 2022, with a primary completion date of September 3, 2026 and study completion of October 5, 2026, according to the record, which was last updated on November 6, 2026.

The study was designed as a multi-center, open-label, randomized, active-controlled, Phase III trial in which participants were randomized to either JDQ443 or docetaxel.¹ Patients on docetaxel could switch to JDQ443 if their disease progressed, as participants randomized to the docetaxel arm had the opportunity to cross over to JDQ443 at disease progression per RECIST 1.1 by local investigator assessment.¹

Eligible patients had locally advanced or metastatic stage IIIB/IIIC or IV KRAS G12C mutant non-small cell lung cancer and had received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.¹

Novartis had planned to randomize approximately 360 participants to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.¹ However, following the decision to halt enrollment for business reasons, a total of 95 participants were randomized.¹

The trial's primary outcome was progression-free survival, defined as the time from date of randomization to the date of event defined as the first documented disease progression based on local Investigator assessment per RECIST 1.1 criteria or death due to any cause.¹ The study enrolled across 51 sites in 25 countries, including the United States, Argentina, Australia, Canada, and China.¹