A phase II study of ipilimumab, nivolumab, and radiotherapy for advanced NSCLC

JRCT ID: jRCTs021220003

Registered date:19/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 19/08/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Patient will receive 10 fractions of radiotherapy as determined by the location of the lesions to be irradiated.
The patient will begin concurrent immunotherapy(ipilimumab and nivolumab) within seven days after starting radiotherapy (30Gy/10fraction). The patient will receive immunotherapy for a maximum of 24 months.

Outcome(s)

• Primary Outcome: Objective Response Rate
• Secondary Outcome: One year Progression-Free survival Rate , Disease Control Rate, Progression-Free survival, Overall Survival,Safety profiles

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically or cytologically confirmed NSCLC
2) Have a histologic diagnosis of stage IIIB, IIIC, IV,or recurrent NSCLC.
3) No sensitizing EGFR mutations or known ALK alterations.
4) Patients must be planning to receive ipilimumab and nivolumab therapy.
5) Have at least one metastatic site for radiation therapy(30Gy/10Fraction).
6) Aged >=20, at the time of consent
7) ECOG PS 0-1
8) Have at least one measurable lesion outside the field of irradiation by CT or MRI per RECIST 1.1 criteria
9) Have adequate organ function
10) Patients must be expected to survive more than three months.
11) Ability to understand and the willingness to sign a written informed consent document

Exclude criteria

1) Patients with sensitizing EGFR mutations or ALK alterations.
2) Patients with a past history of immunotherapy or radiation therapy.
3) Patients with symptomatic brain metastases.
4) Patients with an active autoimmune disease.
5) Patients with a past history of organ transplantation.
6) Patients with severe complications.
7) Patients with a known positive test for hepatitis B virus indicating acute or chronic infection.
8) Patients with interstitial lung disease by CT.
9) Patients with a condition requiring systemic treatment with corticosteroids.
10) Patients with pleural effusion requiring drainage.
11) Patients who are pregnant or lactating.
12) Patients with a past history of drug hypersensitivity.
13) Patients who have additional active malignancies.
14) Patients who are judged inappropriate for the clinical trial by doctors.

Related Information

• Primary Sponsor: Miyauchi Eisaku
• Secondary Sponsor: NPO North East Japan Study Group,NPO North East Japan Study Group