Clinical trial Recruiting at 399 sites Phase2; Phase3 Interventional Ages 18 and up

Combining cemiplimab with standard treatment for advanced lung cancer

Official title: A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Run by SWOG Cancer Research Network · NCT06616584 · Data updated 2026-11-12

This study is testing if adding the immunotherapy drug cemiplimab to standard treatments can help people with advanced lung cancer live longer and feel better compared to just the standard treatments alone.

More Recurrent Lung Non-Small Cell Carcinoma trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment378 (estimated)
SponsorSWOG Cancer Research Network
Research network
Drugs / interventionschemotherapy, immunotherapy, radiation, cemiplimab, ramucirumab
Locations413 sites (Daphne, Alabama and 412 other locations)
StatusRecruiting
StartedMay 22, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2028
Registry record updatedOctober 9, 2026
Trial IDNCT06616584 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with stage IV or recurrent non-small cell lung cancer who have previously been treated with platinum-based chemotherapy and immunotherapy.

Probably not a fit

Patients who have not received prior treatment with platinum chemotherapy or immunotherapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of adding the immunotherapy drug cemiplimab to the standard treatment regimen of docetaxel and ramucirumab for patients with advanced non-small cell lung cancer (NSCLC) who have previously undergone platinum chemotherapy and immunotherapy. The study aims to compare overall survival and progression-free survival between patients receiving the combination treatment versus those receiving standard treatment alone. Participants will be monitored for response rates, disease control, and potential side effects, with a focus on various subgroups based on tumor characteristics and patient performance status.

Why it matters

Potential benefit: If successful, this treatment approach could improve survival rates and quality of life for patients with advanced lung cancer.

How similar studies have gone: Other studies have shown promise in using immunotherapy in combination with standard treatments for lung cancer, suggesting a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
* Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:

  * If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease
  * If they experienced disease progression more than (\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
* Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
* Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
* Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen
* Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met
* Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization
* Participants must not have received prior therapy with docetaxel for this disease
* Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study
* Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
* Hemoglobin ≥ 9.0 g/dL (within 28 days prior to randomization)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN
* Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization
* Participants must have a urinary protein test performed within 28 days prior to randomization
* Participants' most recent Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization
* Participants must have a completed medical history and physical exam within 28 days prior to randomization
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator
* Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization
* Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Participants must not have any history of primary immunodeficiency
* Participants must be able to safely receive study therapy and must not have experienced the following:

  * Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous/nonexfoliative rash
  * Any unresolved grade 2 immune-mediated adverse event
  * Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
  * Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
* Participants must not have any history of organ transplant that requires use of immunosuppressives
* Participants must not have received a live or live attenuated vaccine within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed
* Participants must not have clinical signs or symptoms of active tuberculosis infection
* Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
* Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
* Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization
* Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization
* Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia
* Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
* Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1/2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer
* Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants
* Participants must not have cirrhosis at a level of Child-Pugh B (or worse) AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis, OR any degree of cirrhosis
* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
* Participants must be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Where it's running

  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
    Daphne, Alabama, United States
    Recruiting
  • Thomas Hospital
    Fairhope, Alabama, United States
    Recruiting
  • Mobile Infirmary Medical Center
    Mobile, Alabama, United States
    Recruiting
  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
    Saraland, Alabama, United States
    Recruiting
  • Banner University Medical Center - Tucson
    Tucson, Arizona, United States
    Recruiting
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona, United States
    Recruiting
Show 44 more locations
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    Jonesboro, Arkansas, United States
    Recruiting
  • Kaiser Permanente-Anaheim
    Anaheim, California, United States
    Recruiting
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California, United States
    Recruiting
  • Kaiser Permanente-Bellflower
    Bellflower, California, United States
    Recruiting
  • Tower Cancer Research Foundation
    Beverly Hills, California, United States
    Recruiting
  • Marshall Cancer Center
    Cameron Park, California, United States
    Recruiting
  • Enloe Medical Center
    Chico, California, United States
    Recruiting
  • City of Hope Comprehensive Cancer Center
    Duarte, California, United States
    Recruiting
  • Kaiser Permanente-Fontana
    Fontana, California, United States
    Recruiting
  • Kaiser Permanente Fresno Orchard Plaza
    Fresno, California, United States
    Recruiting
  • Kaiser Permanente-Fresno
    Fresno, California, United States
    Recruiting
  • Kaiser Permanente South Bay
    Harbor City, California, United States
    Recruiting
  • City of Hope at Irvine Lennar
    Irvine, California, United States
    Recruiting
  • Kaiser Permanente-Irvine
    Irvine, California, United States
    Recruiting
  • UC San Diego Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • City of Hope Antelope Valley
    Lancaster, California, United States
    Recruiting
  • Loma Linda University Medical Center
    Loma Linda, California, United States
    Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, United States
    Recruiting
  • Kaiser Permanente West Los Angeles
    Los Angeles, California, United States
    Recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
    Recruiting
  • Fremont - Rideout Cancer Center
    Marysville, California, United States
    Recruiting
  • Mather Veteran Affairs Medical Center
    Mather, California, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California, United States
    Recruiting
  • Kaiser Permanente-Ontario
    Ontario, California, United States
    Recruiting
  • VA Palo Alto Health Care System
    Palo Alto, California, United States
    Recruiting
  • Kaiser Permanente - Panorama City
    Panorama City, California, United States
    Recruiting
  • Kaiser Permanente-Riverside
    Riverside, California, United States
    Recruiting
  • Kaiser Permanente-Roseville
    Roseville, California, United States
    Recruiting
  • Kaiser Permanente Downtown Commons
    Sacramento, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • Kaiser Permanente-San Diego Zion
    San Diego, California, United States
    Recruiting
  • Kaiser Permanente-San Francisco
    San Francisco, California, United States
    Recruiting
  • Veterans Affairs Medical Center - San Francisco
    San Francisco, California, United States
    Recruiting
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, United States
    Recruiting
  • Kaiser Permanente San Leandro
    San Leandro, California, United States
    Recruiting
  • Kaiser Permanente-San Marcos
    San Marcos, California, United States
    Recruiting
  • Mills Health Center
    San Mateo, California, United States
    Recruiting
  • Kaiser San Rafael-Gallinas
    San Rafael, California, United States
    Recruiting
  • Ridley-Tree Cancer Center
    Santa Barbara, California, United States
    Recruiting
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, United States
    Recruiting
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, United States
    Recruiting
  • Cedars-Sinai Cancer - Tarzana
    Tarzana, California, United States
    Recruiting
  • City of Hope South Bay
    Torrance, California, United States
    Recruiting
  • Torrance Memorial Physician Network - Cancer Care
    Torrance, California, United States
    Recruiting

+363 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Saiama N Waqar — SWOG Cancer Research Network
  • Study coordinator: Jennifer Beeler
  • Email: jbeeler@swog.org
  • Phone: 210-614-8808

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.