NSCLC Lung Cancer

Treatment for NSCLC Lung Cancer

Study name: INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non‐Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature‐driven Analysis

Description: Researchers at the WL Nugent Cancer Center are conducting a clinical trial for treating non-squamous, non-small cell lung cancer (NSCLC) to determine if early treatment with an immunotherapy medication improves patient outcomes. Immunotherapy medications use your body’s immune system to fight cancer. Additionally, the study assesses whether additional treatment with chemotherapy following immunotherapy alone also improves overall survival for patients with NSCLC. 

• Group 1 (investigational treatment):  First receive immunotherapy medication (pembrolizumab) alone. If disease gets worse, receive chemotherapy medications (carboplatin and pemetrexed).
• Group 2 (investigational treatment):  First receive immunotherapy medication (pembrolizumab) alone. If disease gets worse, receive immunotherapy medication (pembrolizumab) combined with chemotherapy medications (carboplatin and pemetrexed).
• Group 3 (current standard treatment):  Receive immunotherapy medication (pembrolizumab) combined with chemotherapy medications (carboplatin and pemetrexed). If disease gets worse, you will proceed to another therapy determined by your doctor

Who can participate?

This study is open to men and women age 18 and over who:

• Have a been diagnosed with Stage 4 non-squamous, non-small cell lung cancer (Stage 3 NSCLC may be eligible)
• Tested positive for tumor marker PD-L1.

What to expect

• You will meet with your doctor to discuss what is involved in the study and the possible benefits and risks. If you and your doctor agree this clinical trial is right for you, you will be asked to sign a consent form.

• This is a randomized study, where you will be assigned by chance to one of the treatment groups listed above.

• You will periodically complete questionnaires about your condition, side-effects from treatment, etc.

• Blood samples may be collected before, during, and after treatment for study analysis.

Please talk with your doctor about whether this clinical trial is right for you.