A phase II study of additional effect of palliative radiotherapy combined with immune check point inhibitors plus chemotherapy for patients with advanced non-small-cell lung cancer.

JRCT ID: jRCTs071200046

Registered date:27/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 16/02/2021
• Target sample size: 43
• Study type: Interventional

Intervention(s)

Radiotherapy shall be carried out for lesions scheduled for palliative irradiation.
The following chemotherapy shall be performed at the same time as the radiation treatment or sequentially (7 days before the start to within 14 days after the radiation treatment completion)
Non-squamous cell carcinoma: cisplatin (or carboplatin)and pemetrexed and pembrolizumab (up to 4 courses) - pemetrexed and pembrolizumab (up to PD)
Squamous cell carcinoma:carboplatin and paclitaxel or nab-paclitaxel and pembrolizumab (up to 4 courses) - pembrolizumab (up to PD)
In addition, maintenance therapy shall be allowed to be completed in 31 courses (35 courses in total)

Outcome(s)

• Primary Outcome: progression free survival rate at 12 months (12mPFS rate)

Secondary Outcome

Progression free survival (PFS)
Overall survival rate at 12 months(12mOS rate)
Overall response rate(ORR)
Duration of response(DOR)
Adverse event rate
Serious adverse event rate
Incidence of PD-L1

Key inclusion & exclusion criteria

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

Include criteria

1) Patients who are histologically or cytologically diagnosed as non-small cell lung cancer.
2) Patients with stage III, IV or post-operative recurrence incapable of radical radiation therapy.ng cancer.
3) Palliative radiation therapy is planned for lesions where lung field does not fall within the irradiation range. However,palliative radiation therapy for thoracic vertebra/rib metastasis, supraclavicular lymph node metastasis, superior vena cava syndrome shall be allowed.
4)The presence or absence of measurable lesions does not matter.
5) No meningeal carcinomatosis or spinal metastasis requiring surgery.
6) Driver gene mutation is negative in only patients with non-squamous cell carcinoma.It is eligible regardless of the presence or absence of driver gene mutation in cases of squamous cell carcinoma.
7) Patients are >=20 years of age (age at the time of enrollment).
8)Performance status (ECOG) 0 - 1.
9) No pericardial effusion,pleural effusion,and ascites of Grade 3 or higher.
10) No surgery with organ resection within 28 days before enrollment.
11) No systemic chemotherapy, including treatment for other cancer types within 5 years.
12) Main organ function is maintained. The latest test value within 14 days before enrollment (possible on the same day two weeks before the enrollment date) satisfies all the following:
1.Number of neutrophils >= 1,500/uL
2.Hgb >= 9.0g/dL
3.Platelet count >= 10x10^4 /uL
4.Total bilirubin <= 1.5 mg/dL
5.AST (GOT) <= 100 U/L
6.ALT (GPT) <= 100 U/L
7.Serum creatinine <= 1.5 mg/dL
8.SpO2(Room air)>=92%
However, if pemetrexed is scheduled to be administered, creatinine clearance >= 50 mL/min should be confirmed.
13) Patients without history of complication of autoimmune disease or chronic or recurrent autoimmune disease.
14) Prognosis of 3 months or more is expected.
15) Patients providing the written informed consent.

Exclude criteria

1) Patients with active double cancer.
2) Patients with infectious disease requiring systemic treatment.
3) Patients with findings of interstitial pneumonia and pulmonary fibrosis that are difficult to undergo chemotherapy.
4) Patients who are difficult for the participation in the study by complication of mental disease or psychiatric symptom.
5) Pregnant women, lactating women, women who may be pregnant at present, or women who are not willing to use contraception. Male patients who want their partner to become pregnant. However, lactating women shall be allowed if they can be weaned.
6) Patients with continuous systemic administration of steroids or immunosuppressants other than anti-edema measures for autoimmune diseases and brain/spinal cord metastases.
7) Patients with uncontrollable diabetes mellitus and hypertension, which are poorly controlled by proper treatment.
8) Patients with complication of unstable angina pectoris (angina pectoris onset within latest 3 weeks before enrollment or with progression of spasm) or anamnesis of myocardial infarction within 6 months
9) HBs antigen positive.
10) History of hypersensitivity to cisplatin, carboplatin, pemetrexed, paclitaxel, pembrolizumab, albumin.
11) Any other patients who are regarded as unsuitable for this study by the investigators.

Related Information

• Primary Sponsor: Imaizumi Kazuyoshi