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Non-Small Cell Lung CancerPhase 2REVIVENCT07603856

A Study Evaluating The Combination of Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer

A Phase 2 study testing Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab), Investigator Choice Chemotherapy (for example docetaxel with or without ramucirumab, gemcitabine, or other National Comprehensive Cancer Network (NCCN)-recommended treatments) and Ablative Hypofractionated Radiotherapy in people with Non-Small Cell Lung Cancer and Metastatic Lung Cancer, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Current clinical trials testing the combination of immunotherapy with radiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab), Investigator Choice Chemotherapy (for example docetaxel with or without ramucirumab, gemcitabine, or other National Comprehensive Cancer Network (NCCN)-recommended treatments) and Ablative Hypofractionated Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
12 Dec 2026to 25 Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease-Related Criteria
  • Patients must have histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer (NSCLC) with progression on prior immunotherapy
  • The patient's disease is eligible for SOC treatment with immunotherapy or chemotherapy.
  • Patients must have measurable disease per RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter ≥10 mm (or ≥15 mm short axis for lymph nodes) by CT or MRI
  • Patients must have at least one lesion that meets criteria for hypofractionated ablative RT treatment:
  • Tumor volume 0.25 cc to 65 cc (approximately ≤5 cm maximal dimension)
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  • Located in sites amenable to ablative RT (see radiotherapy section for specific anatomic criteria)
  • Note: Tumors >65 cc may be partially treated to 65 cc volume
  • Prior/Concurrent Therapy Criteria
  • Patients must have received exactly ONE prior line of anti-PD-1 or anti-PD-L1 therapy for non-small cell lung cancer. This therapy may have been given as:
  • Monotherapy
  • In combination with chemotherapy
  • In combination with another immunotherapy such as CTLA-4 inhibition
  • In combination with a targeted therapy, such as adagrasib
  • Special Cases for Neoadjuvant/Adjuvant Immunotherapy:
  • If patient received neoadjuvant, adjuvant, or consolidation anti-PD-1/PD-L1 therapy for Stage I-III disease and progressed ≤365 days from initiation (Cycle 1 Day 1), this counts as the single allowed therapy for advanced disease
  • If patient progressed >365 days from neoadjuvant/adjuvant therapy initiation, this does NOT count as therapy for advanced disease, and patient must have received subsequent anti-PD-1/PD-L1 therapy for Stage IV or recurrent disease
  • Patients with the following sensitizing mutations are ineligible, given known poor response to immunotherapy: EGFR, ALK, ROS1, RET, NTRK, HER2.
  • Patients with the following sensitizing mutations must have previously received at least one of the appropriate targeted therapies, in addition to prior immunotherapy: BRAF, KRAS, MET. Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria is also met.
  • Clinical/Laboratory Criteria
  • Age ≥18 years
  • ECOG Performance Status 0-2 (see Appendix A)
  • Participants must be able to safely receive the investigational drug combination and the investigator's choice of standard of care regimens described in Section 5.1 (Agent Administration), per the current FDA-approved package inserts, treating investigator's discretion, and institutional guidelines.
  • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Because radiation and chemotherapy are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Both men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of immunotherapy, radiation, and/or chemotherapy administration.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients with history of (non-infectious) pneumonitis requiring corticosteroids.
  • Patients with evidence of interstitial lung disease.
  • Patients with uncontrolled intercurrent illness.
  • Pregnant women are excluded from this study. Radiation is considered Class X and chemotherapy such as docetaxel are considered Class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation, immunotherapy, and chemotherapy breastfeeding should be discontinued if the mother is participating in the study.
  • Radiation-Specific Exclusions
  • Patients who have received prior radiation to any of the planned treatment sites (>10% dose overlap)
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  • Patients with lesions in locations not amenable to safe ablative RT delivery, including:
  • Esophagus or stomach directly involved by tumor (unless dose constraints can be met)
  • Small bowel or colon directly involved by tumor (unless dose constraints can be met)
  • Spinal cord lesions with <3 mm clearance between epidural disease and spinal cord

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • o University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Clinical Trials Intake, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Aditya Juloori

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase II Study of Radiotherapy Plus Immune Checkpoint Inhibitor Therapy Versus Standard of Care Chemotherapy in Patients With Metastatic or Relapsed Non-Small Cell Lung Cancer Previously Treated With Immunotherapy

Current clinical trials testing the combination of immunotherapy with radiotherapy.

Being tested
Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab), Investigator Choice Chemotherapy (for example docetaxel with or without ramucirumab, gemcitabine, or other National Comprehensive Cancer Network (NCCN)-recommended treatments), Ablative Hypofractionated Radiotherapy
Keywords
Radiotherapy, Chemotherapy, Immunotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab)Drug

    Participant will receive an FDA approved immunotherapy according to usual routine practice.

  • Investigator Choice Chemotherapy (for example docetaxel with or without ramucirumab, gemcitabine, or other National Comprehensive Cancer Network (NCCN)-recommended treatments)Drug

    Description something along the lines of Participant will receive an FDA approved chemotherapy according to usual routine practice.

  • Ablative Hypofractionated RadiotherapyRadiation

    Participant will receive radiotherapy according to usual routine practice.

Study groups in NCT07603856
Study groupRoleWhat they receive
Radiotherapy (RT) + ImmunotherapyExperimentalParticipants will receive standard immunotherapy of investigator's choice in combination with radiation treatment.
Receives: Drug: Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab); Radiation: Ablative Hypofractionated Radiotherapy
Standard Chemotherapy (Investigator's Choice")Active comparatorParticipants will receive standard chemotherapy of investigator's choice.
Receives: Drug: Investigator Choice Chemotherapy (for example docetaxel with or without ramucirumab, gemcitabine, or other National Comprehensive Cancer Network (NCCN)-recommended treatments)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    To compare progression-free survival (PFS) in patients with metastatic or relapsed non-small cell lung cancer (mNSCLC) who have progressed after immunotherapy-based treatment, randomized to investigators choice standard of care immunotherapy plus hypofractionated ablative radiotherapy versus investigators' choice of standard of care chemotherapy.

    Measured: 48 months

Secondary outcomes (5)

  1. Overall survival (OS)

    To compare overall survival (OS) between treatment arms

    Measured: 48 months

  2. Objective response rates (ORR)

    To compare objective response rates (ORR) between treatment arms.

    Measured: 48 months

  3. Correlation between amount of L1RE1 (LINE1 retrotransposable element 1) and clinical response to treatment

    Dose amount of L1RE1 in blood correlate to clinical response (for example are higher levels of the protein in the blood a sign of response to treatment)?

    Measured: 24 months

  4. Pharmacodynamic Properties

    Establishing the pharmacodynamic properties of L1RE1 clearance during treatment. L1RE1 serum levels will be measured descriptively using NPX (normalized protein expression) .

    Measured: 24 months

  5. Safety of Giving Ablative Radiation and Immunotherapy Together

    Number of Common Terminology Criteria for Adverse Events (CTCAE) version 5 Grade 3 adverse events

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start12 Dec 2026 (estimated)
  3. Primary completion25 Jun 2030 (estimated)
  4. Study completion25 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603856
Sponsor's protocol ID
IRB25-1914
Acronym
REVIVE
Status last verified
May 2026
First submitted
9 Mar 2026
Last updated
16 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab), Investigator Choice Chemotherapy (for example docetaxel with or without ramucirumab, gemcitabine, or other National Comprehensive Cancer Network (NCCN)-recommended treatments) and Ablative Hypofractionated Radiotherapy in people with Non-Small Cell Lung Cancer and Metastatic Lung Cancer, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07603856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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