Official title: “Overcoming resistance to immunotherapy combining gemcitabine with ivonescimab in advanced NSCLC”, i.e. using a combination of gemcitabine and ivonescimab to treat patients with advanced non-small cell lung cancer (NSCLC) whose disease continues to progress while they are receiving immunotherapy. A multicentre, single-arm, open-label Phase II trial.

Non-small cell lung cancer (NSCLC) is one of the most common cancers. If the cancer has already spread widely in the chest or metastases have formed in other organs, one of the standard treatments is immunotherapy. In most patients, however, the disease will progress after a certain amount of time.

In this clinical trial involving people with advanced NSCLC whose initial immunotherapy is no longer effective, we are investigating a treatment that combines two active substances, gemcitabine and ivonescimab. Gemcitabine is licensed in Switzerland for chemotherapy in various types of cancer. Ivonescimab is licensed in China for immunotherapy of NSCLC, but not in Switzerland. Clinical trials have shown that ivonescimab is more effective than other drugs in people with advanced NSCLC.

It is hoped that this trial will show that the combination of gemcitabine and ivonescimab is a safe and effective treatment option for patients with advanced NSCLC whose initial immunotherapy is no longer effective.

Disease we are investigating in this trial 
Non-small cell lung cancer at an advanced stage (spread widely in the chest or metastases in other organs) 

Treatment we are evaluating in this trial 
Trial participants will all receive the same treatment combining gemcitabine with ivonescimab. The medicines will be given as an infusion through a vein. 

Inclusion criteria 
Everyone taking part in the trial must fulfil various requirements. The most important include:

• Age: at least 18 years.
• Suffering from advanced NSCLC that has already been treated at least once by immunotherapy, but now this therapy is no longer effective (return or progression of the disease)

Exclusion criteria
Not everyone with advanced NSCLC may take part in the trial. The main criteria that would prevent someone from participating in the trial include:

• Previously treated at least once with a combination of gemcitabine and immunotherapy.
• The detection of certain genetic changes in the cancer cells, which means the person affected requires a different treatment to the trial medication.
• Brain metastases that are causing symptoms.
• The presence of other significant illnesses, for instance a serious infectious disease, unstable heart disease or an increased risk of bleeding.