Clinical Trial Summary (S1800E)
Adding Cemiplimab to Usual Treatment for People with Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment with Platinum Chemotherapy and Immunotherapy
What is the purpose of this clinical trial?
This study tests treatment for advanced non-small cell lung cancer (NSCLC). Treatment in the study is for people with cancer that has worsened after usual treatment approaches.
When initial treatments stop working, doctors may recommend a combination of 2 drugs, ramucirumab and docetaxel.
- Ramucirumab blocks tumors from forming new blood vessels so the cancer can’t grow.
- Docetaxel is a chemotherapy drug that kills cancer cells.
In this study, researchers want to learn if adding the drug cemiplimab to the combination of ramucirumab and docetaxel can improve treatment.
- Cemiplimab is an immunotherapy drug that blocks a protein (called PD-1) in certain immune cells. This helps your own body fight the cancer.
Combining cemiplimab with ramucirumab and docetaxel has not yet been approved by the Food and Drug Administration (FDA) for treating advanced lung cancer.
This trial is set up to find out:
- If adding cemiplimab to the usual treatment can help people live longer with advanced NSCLC
- What side effects people have from adding cemiplimab to the usual treatment
Why is this trial important?
Doctors want to find better ways to treat NSCLC when previous chemotherapy and immunotherapy options stop working. Combining cemiplimab with ramucirumab and docetaxel offers an approach that targets the cancer in several different ways. Evidence from previous research suggests that advanced NSCLC may respond better to this combination of drugs. This trial is an important step toward improving treatment options for patients who have already received standard treatments.
Who can be in this trial?
This trial is for adults, age 18 or older, with non-small cell lung cancer that is stage 4 or has come back after previous treatment.
This trial may be for people who:
- Had previous immunotherapy with an anti-PD1 or anti- PDL1 drug (such as pembrolizumab, atezolizumab, durvalumab, or nivolumab)
- Had previous treatment with a platinum-based chemotherapy drug (such as cisplatin or carboplatin)
- Have cancer that has gotten worse after these previous treatments
This trial is not for people who:
- Already received the drug docetaxel in previous treatment
- Have another cancer that may make it unsafe to get treatment in this study
- Are pregnant
Talk with your doctor to learn more about who can join this study.
What treatments will I get?
If you join this study, you will be randomly assigned to one of 2 study groups.
| Group 1: usual treatment | Group 2: usual treatment + study drug |
|
|
ramucirumab + docetaxel
|
 |
ramucirumab + docetaxel + cemiplimab (study drug) |
Your doctor will not have control over which group you will be assigned to. This helps make sure the study results are fair and reliable.
How long will I be in the trial?
You will get treatment in the study for as long as you benefit from it. You may choose to stop being in the study for any reason at any time. Your doctor may stop your treatment if side effects become too severe or your condition gets worse.
If you stop getting treatment, you will have follow-up visits with the study team until the end of 3 years.
This trial is part of a larger study called Lung-MAP. If your condition gets worse, you may have the option to join another Lung-MAP study.
Are there costs? Will I get paid?
The study drug cemiplimab is provided free in this study.
Check with your health care provider and insurance provider about what costs will and won’t be covered in the study. You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to ClinicalTrials.gov and search the national clinical trial number: NCT06616584
- Go to lung-map.org/patients
- For a list of trial locations, visit swog.org/NCI-S1800E
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S1800E
NCT Number
NCT06616584
Full Trial Title
A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or without Cemiplimab (REGN2810) for Participants Previously Treated with Platinum-Based Chemotherapy i ? ? Where can I find more information about this trial? Key information This trial is for adults 18 years or older being • [Primary objective] and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non- Matched Sub-Study)
Trial Sponsors
SWOG Cancer Research Network
Publication Date