AstraZeneca Halts KRASG12D Trial, Withdraws Ovarian Cancer Study, Completes Lung Cancer Review

AstraZeneca has terminated its ALAFOSS-01 Phase I/IIa trial of AZD0022 in adults with advanced cancers carrying a KRASG12D mutation. The study aimed to test safety, dosing, and early signs of benefit in tumors such as NSCLC, pancreatic, and colorectal cancer. The listing now shows the study status as terminated, with the latest update posted March 5, 2026, signaling that AZD0022 will not move forward under this protocol.

The trial tested AZD0022, an oral drug designed to block KRASG12D, a key cancer driver mutation. It was assessed alone and in combination with the antibody drug cetuximab, which targets EGFR and is already used in some colorectal and head and neck cancers. The study used an interventional design with non-random allocation, meaning all patients received active treatment rather than placebo. It was open-label and sequential, so both doctors and patients knew which treatment was given, and dose levels were adjusted step-by-step to find an optimal and safe range. The trial began after initial submission in August 2024, with early phases focused on dose escalation and safety.

Separately, AstraZeneca has withdrawn a planned Phase I/II master protocol to investigate biomarker-guided novel anticancer agents for the treatment of participants with advanced or recurrent ovarian cancer. The main drug in the first planned substudy was saruparib, an oral cancer pill from AstraZeneca's pipeline. It was to be tested alone in patients with BRCA gene mutations, aiming to slow tumor growth and extend survival while keeping side effects manageable.

The trial was designed as an interventional study with one treatment group and no placebo or randomization. All enrolled patients would have received saruparib, with doctors and patients aware of the treatment. The study was first submitted on 24 June 2025. On 18 February 2026, the listing was updated to show the status as "withdrawn," indicating the study will not proceed as planned and that timelines for first and final results are now off the table.

In a separate development, AstraZeneca completed a real-world review titled "Understanding Non-small Cell Lung Cancer Patient Characteristics, Treatment Patterns and Outcomes." The project is not a drug test but a chart audit run across several countries. Doctors share anonymized patient records to show how systemic anti-cancer treatments are actually used. The design is observational and retrospective, meaning researchers look back at existing patient files rather than giving new medicine. There is no randomization or blinding, so the focus is on spotting patterns in treatment choice and outcomes rather than proving that one specific drug is better than another.

The study started after its first submission on October 8, 2025, and is now listed as completed, so data collection is finished. The latest update was filed on March 9, 2026, signaling that analysis and reporting are in progress and that new insights on real-world non-small cell lung cancer care should follow.