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

ConditionsNon-Small Cell Lung CancerMetastatic Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

Current clinical trials testing the combination of immunotherapy with radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 Radiotherapy

    Radiation

    Participant will receive radiotherapy according to usual routine practice.

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: Radiotherapy (RT) + ImmunotherapyExperimental treatment 2 interventions
Group B: Standard Chemotherapy (Investigator's Choice")Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
48 months

Secondary outcomes

1

Overall survival (OS)

To compare overall survival (OS) between treatment arms

Time frame
48 months
2

Objective response rates (ORR)

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

Time frame
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)?

Time frame
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) .

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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