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Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study

Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study - OLCSG2001

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041778
Enrollment
19
Registered
2020-11-15
Start date
2020-11-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small-cell lung cancer

Interventions

sequential radiation therapy followed by immune checkpoint inhibitor(ICI)+ cytotoxic chemotherapy continuation

Sponsors

National Hospital Organization Shikoku Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -The patient has histologically or cytologically confirmed non-small cell lung cancer. -The patient has clinical stage III, IV, or post-operative recurrent non-small cell lung cancer that is not amenable to radical resection or radical radiation therapy. -The patient has Oligo-PD after treatment with an immune checkpoint inhibitor (ICI) plus platinum-based cytotoxic anticancer agent. <The Oligo-PD is defined as meeting all four of the following.> 1.Two or more courses of ICI+chemo induction and two or more courses of maintenance therapy, and tumor reduction of SD or greater with reduction. 2.The lesions that do not result in PD on RECIST as a whole if they are not exacerbated after ICI+chemo maintenance therapy and there is no exacerbation of the lesions. 3.The lesion must have no more than 3 lesions, including brain metastases, that are not in contact or fused by CT or MRI, respectively. However, lymph node metastases will be treated as a single lesion if the radiotherapist determines that the area can be irradiated at once. 4.Cases of cancerous pleural effusion, cancerous pericarditis, exacerbation in lymphangitis or cases of cancerous meningitis complications are excluded. -All of these Oligo-PDs are capable of additional radiation exposure. -An ECOG performance status (PS) of 0 to 1. -Major organ function is intact. -The patient is judged to be alive for at least 3 months from the date of enrollment.

Exclusion criteria

Exclusion criteria: Patients with serious complications or history are excluded.

Design outcomes

Primary

MeasureTime frame
1-year survival rate

Secondary

MeasureTime frame
Overall survival, progression-free survival, safety, post-treatment status

Countries

Japan

Contacts

Public ContactTakashi Ninomiya

National Hospital Organization Shikoku Cancer Center Clinical Research Promotion Department

ninomiya.takashi.se@mail.hosp.go.jp089-999-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026