A phase II study of ipilimumab, nivolumab, and radiotherapy for advanced NSCLC
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-jRCTs021220003
- Lead Sponsor
- Miyauchi Eisaku
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method