Cemiplimab with Docetaxel for Advanced Lung Cancer

Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)

Recruiting Phase 2 Phase 3 Interventional Study
Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
378 (estimated)
Sponsor
SWOG Cancer Research Network · Research network
Who this trial is looking for

This trial is looking for people with advanced non-small cell lung cancer who have already received treatment. Participants will take the medication cemiplimab along with standard treatments to see if it helps improve outcomes.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have advanced non-small cell lung cancer.
  • I have had one previous anti-PD-1 or anti-PD-L1 therapy.
  • I have experienced disease progression after my last anti-PD-1 or anti-PD-L1 therapy.
  • I have received platinum-based chemotherapy and had disease progression.
  • I have had a CT or MRI scan of my brain within the last 42 days.
  • I have a good performance status (ECOG score of 0-1).
  • I have measurable or non-measurable disease documented by CT or MRI.
  • I have recovered from the side effects of my last cancer treatment.

You may not be able to join if

  • I have received prior therapy with docetaxel for this disease.
  • I have undergone major surgery within the last 28 days.
  • I have received any palliative radiation therapy within the last 14 days.
  • I am planning to receive other cancer treatments while on this study.
  • I have a known chronic hepatitis B virus infection that is not undetectable.
  • I have not been treated and cured for hepatitis C virus infection.
  • I have had any serious postoperative complications in the last 2 months.
  • I have a history of certain molecular alterations without prior approved therapy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol * Participants must have measurable or non-measurable disease documented by CT or MRI.…
Contacts

Jennifer Beeler

210-614-8808

jbeeler@swog.org

CONTACT

SWOG Network Operations Center

protocols@swog.org

CONTACT