Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial.

What was studied

This trial tested glecirasib taken with sitneprotafib, both as pills. It was done in people with lung cancer with a KRASG12C gene change. The cancer was advanced or had spread. It took place at 26 hospitals in China. Everyone got the drugs, and there was no comparison group. The first part looked at safety and doses. The second part looked at how often tumours shrank.

What they found

In all, 171 people with lung cancer took part. They were followed for a median of 14·5 months. Side effects from the drugs were very common. Grade 3-4 side effects happened in 78 people. Common ones were low blood counts and changes in liver tests. Fat levels in the blood also went up often. One problem limited the dose, and it was at the top dose. It was grade 3 lung inflammation. No one died from side effects. Tumours shrank in 72 of 102 people not treated before. They shrank in 19 of 39 people treated before, but not with KRASG12C drugs. Results were weaker in 30 people who had KRASG12C drugs before.

What it means for patients

The authors say the pair of drugs showed hopeful early results. They say the side effects could be handled. The effect looked strongest in people not treated before. This pair of drugs does not use chemo. The authors say a phase 3 trial should now compare it with usual care.

Why it is not certain yet

There was no comparison group, so the effect is hard to judge. Doctors in the trial judged the tumour results themselves. Several doses and schedules were tested across groups. The trial was done only in China. The drug maker paid for the study. The trial is still taking in new people.

Source

Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial.

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