MSD begins KANDLELIT-007 trial of calderasib for NSCLC

Merck & Co (MSD) has commenced the KANDLELIT-007 Phase III trial to assess calderasib (MK-1084), with Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

Calderasib is an investigational oral Kirsten rat sarcoma viral oncogene homologue. (KRAS) G12C inhibitor.

The unblinded, randomised, multicentre, open-label trial will compare orally administered calderasib with subcutaneous Keytruda Qlex against subcutaneous Keytruda Qlex paired with intravenous pemetrexed and chemotherapy (carboplatin or cisplatin).

Newly diagnosed patients with KRAS G12C-mutant advanced or metastatic nonsquamous NSCLC will be enrolled in the trial.

In both groups, Keytruda Qlex will be given every six weeks. The comparator arm also includes pemetrexed on days one and 22 of each three-week cycle and platinum chemotherapy on days one and 22 for up to two cycles.

MSD aims to enrol around 675 patients worldwide. The primary endpoint is progression-free survival (PFS) in those whose tumours express programmed death-ligand 1 (PD-L1) with a tumour proportion score (TPS) of at least 1%.

Secondary endpoints include overall survival, PFS in all participants, duration of response, overall response rate, and safety in both PD-L1 expressors and the entire study population.

MSD Research Laboratories global clinical development vice-president Dr Gregory Lubiniecki said: “While outcomes for patients with NSCLC have significantly improved over the last decade, we know there is more work to do. KRAS is the most frequently mutated oncogene in cancer, and the KRAS G12C mutation occurs in approximately 4% to 14% of all patients with lung cancer globally.

“By pairing our oral calderasib candidate with subcutaneously administered Keytruda Qlex in this trial, we will evaluate whether this chemotherapy-free combination that requires no intravenous access may help improve outcomes for patients with KRAS G12C-mutant NSCLC.”

MSD, Astex Pharmaceuticals (UK), and Taiho Pharmaceutical are jointly developing calderasib as part of a collaboration that commenced in January 2020.

In November 2025, MSD reported that the Phase II Cadence trial of Winrevair for combined post- and precapillary pulmonary hypertension (CpcPH) caused by heart failure with preserved ejection fraction (HFpEF) had met its primary endpoint.

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