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New treatment option for Non-Small Cell Lung Cancer
Official title A Study Evaluating The Combination of Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07603856
What this study is testing
What is Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab)?
Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab) is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Current clinical trials testing the combination of immunotherapy with radiotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Disease-Related Criteria
- Patients must have histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer (NSCLC) with progression on prior...
- 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...
- Patients must have at least one lesion that meets criteria for hypofractionated ablative RT treatment:
You likely can't join if
- 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...
- Patients who have received prior radiation to any of the planned treatment sites (\>10% dose overlap)
- Patients with lesions in locations not amenable to safe ablative RT delivery, including:
See the full eligibility criteria
- 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...
- 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)
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- Patients who have received prior radiation to any of the planned treatment sites (\>10% dose overlap)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.