A Phase II Study of Nivolumab and Ipilimumab in Combination with Chemotherapy after Lung SBRT in Stage IV NSCLC.

JRCT ID: jRCTs031210688

Registered date:22/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Stage IV non-small cell lung cancer
• Date of first enrollment: 15/06/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Thoracic radiotherapy followed by nivolumab + ipilimumab + platinum-based chemotherapy.

Radiotherapy:
Thoracic radiotherapy is administered to the primary tumor and hilar and mediastinal lymph node metastases with the largest tumor size at 8 gray once daily, every other day and total 3 times and 24 gray.

Chemotherapy:
cisplatin (75 mg/m2) or carboplatin (AUC 5) + pemetrexed (500 mg/m2) + nivolumab (360 mg) + ipilimumab (1 mg/kg) is administered intravenously for non-squamous cell carcinoma, and carboplatin (AUC 6) + paclitaxel (200 mg/m2) + nivolumab (360 mg) + ipilimumab (1 mg/kg) is administered intravenously for squamous cell carcinoma.
Platinum-based chemotherapy is repeated every 3 weeks for up to 2 courses.
Nivolumab is repeated every 3 weeks and ipilimumab is repeated every 6 weeks for up to 2 years.

Outcome(s)

• Primary Outcome: Progression-free survival rate at 6 months after enrollment

Secondary Outcome

1) Progression-free survival
2) Overall survival
3) 1-year progression-free survival rate
4) 1-year survival rate
5) Response rate
6) Safety (incidence and severity of adverse events)

Key inclusion & exclusion criteria

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

Include criteria

(1) Diagnosed as non-small cell lung cancer by either histology or cytology.
(2) Diagnosed as clinical stage IV (UICC-TNM classification, 8th edition) or postoperative recurrence.
(3) No prior systemic chemotherapy for lung cancer.
(4) No history of chemotherapy with immune checkpoint inhibitors for other cancer types.
(5) For non-squamous NSCLC, EGFR gene mutation is negative.
(6) Negative or unknown for ALK fusion gene, ROS1 fusion gene, BRAF (V600E) mutation, MET exon 14 skipping mutation, RET fusion gene, or NTRK fusion gene.
(7) Age 20 years or older at the date of registration.
(8) A baseline Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
(9) PD-L1 (22C3) expression is not required.
(10) Patients must have primary pulmonary lesion, mediastinal or hilar lymph node metastases, or any of them, amenable to radiotherapy.
(11) Patients with measurable lesions.
(12) No symptomatic brain metastases, meningeal carcinomatosis, or spinal metastases requiring radiotherapy or surgery.
(13) No autoimmune disease and no history of chronic or recurrent autoimmune disease.
(14) Patients are expected to survive for at least 12 weeks.
(15) Patients obtain written informed consent.

Exclude criteria

(1) Patients with concurrent multiple cancers or heterogeneous multiple cancers with a disease-free interval of 2 years or less
(2) Patients with interstitial pneumonia, drug-induced interstitial lung disease, or clinically active interstitial lung disease on chest CT scan
(3) Patients with a history of radiotherapy to the chest
(4) Patients with symptoms such as dyspnea associated with SVC syndrome or airway stenosis who require palliative radiotherapy to the chest
(5) Patients who are receiving oxygen
(6) Patients with infections that require systemic treatment.
(7) Patients who are receiving continuous systemic administration of steroids or other immunosuppressive drugs at a dose higher than 10 mg/day of prednisolone equivalent.
(8) Patients with serious complications.

Related Information

• Primary Sponsor: Hosomi Yukio
• Secondary Sponsor: NPO North East Japan Study Group,NPO North East Japan Study Group