Divarasib + Pembrolizumab for Lung Cancer

(Krascendo 2 Trial)

This trial tests the effectiveness of two treatments, divarasib (a new potential drug) and pembrolizumab (an immunotherapy), for people with advanced lung cancer. It focuses on a specific type of lung cancer with a KRAS G12C mutation, which influences cell growth. Participants will receive either the new combination of divarasib and pembrolizumab or the standard treatment of pembrolizumab and chemotherapy drugs. The trial seeks participants who have not previously received treatment for their advanced lung cancer and have a confirmed KRAS G12C mutation. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial requires that you stop any anti-cancer systemic therapy, including hormonal therapy, at least 21 days before joining. You also cannot be on medications that prolong the QT interval or on systemic immunosuppressive or immunostimulatory medications. If you're on antibiotics, you need to stop them 2 weeks before joining.

Research shows that divarasib, when combined with pembrolizumab, has undergone safety testing in people with certain types of lung cancer. In earlier studies, patients with a specific mutation called KRAS G12C received divarasib, which was generally well-tolerated. Some participants experienced side effects, but these were mostly manageable.

Pembrolizumab alone has FDA approval for treating lung cancer and is considered safe for many, though it can cause side effects like tiredness and skin reactions.

Researchers are excited about the combination of Divarasib and Pembrolizumab for lung cancer because it targets cancer in a unique way. Unlike standard treatments like chemotherapy, which attack fast-growing cells broadly, Divarasib specifically inhibits a protein involved in cancer cell growth, potentially leading to fewer side effects. Additionally, Pembrolizumab is an immunotherapy that helps the immune system recognize and fight cancer cells more effectively. This combination could offer a more precise attack on cancer cells, possibly improving outcomes for patients.

This trial will compare two treatment combinations for lung cancer. Studies have shown that divarasib, one of the treatments in this trial, helps patients with a specific type of lung cancer live without disease progression for about 13.8 months on average when used alone. This finding suggests that divarasib may effectively slow cancer. Divarasib is a targeted treatment that specifically attacks a common mutation in certain lung cancers. Pembrolizumab, the other drug in the divarasib combination arm, is an immunotherapy that boosts the body's natural defenses to fight cancer. Early research suggests that using these two treatments together may improve outcomes for patients with this type of lung cancer.⁴⁶⁷⁸⁹