Pembrolizumab dose-optimization study

JRCT ID: jRCTs031230682

Registered date:06/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 06/03/2024
• Target sample size: 450
• Study type: Interventional

Intervention(s)

Patients who agree to "Weight-Based Pembrolizumab Dosing":
For 1 course of 3 weeks, the dose of pembrolizumab is 100 mg for 60 kg or less and 200 mg for more than 60 kg.
For one 6-week course, the dose of pembrolizumab is 200 mg for 60 kg or less and 400 mg for more than 60 kg.
Patients who do not agree to "Weight-Based Pembrolizumab Dosing":
For 1 course of 3 weeks, the dose of pembrolizumab is 200 mg regardless of body weight.
For one 6-week course, the dose of pembrolizumab is 400 mg, regardless of body weight.

Outcome(s)

• Primary Outcome: Progression free survival(PFS)

Secondary Outcome

(1)Overall Survival(OS)
(2)Duration of Response(DoR)
(3)Time to Treatment Failure(TTF)
(4)Response Rate(RR)
(5)Adverse Events Rate

Key inclusion & exclusion criteria

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

Include criteria

(1) Non-small cell lung cancer diagnosed by either histology (resection specimen), biopsy, or cytology.
(2) Patient has stage III or stage IV disease not amenable to radical chemoradiotherapy, postoperative recurrence, or recurrence after radical chemoradiotherapy.
*Stage is defined using the Union for International Cancer Control (UICC)TNM Classification of Malignant Tumors (2017, 8th edition).
(3) For non-squamous cell carcinoma, EGFR gene mutations (exon19 partial deletion mutation, exon21 L858R point mutation, other uncommon mutation) are negative or unknown (unknown includes untested/poor specimen and no test results available at the time of registration). EGFR gene mutation is not required for squamous cell carcinoma.
(4) Negative or unknown for ALK fusion gene, ROS1 fusion gene, BRAF (V600E) mutation, MET exon14 skipping mutation, RET fusion gene, or NTRK fusion gene (unknown includes untested/poor specimen or no test results available at enrollment).
(5) No history of systemic medical therapy for the cancer for which the subject is enrolled in this study. However, pre- and post-operative adjuvant therapy, excluding immune checkpoint inhibitors, will be considered eligible if at least 2 years have elapsed since the date of last administration. In addition, a history of postoperative UFT therapy is eligible regardless of the number of days elapsed since the date of the last administration.
(6) Patients are scheduled to receive pembrolizumab alone or in combination with platinum-based chemotherapy plus pembrolizumab.
(7) PD-L1 (22C3) expression meets one of the following criteria.
1) Planned treatment with pembrolizumab alone: 50% or more
2) Any expression if planned to be treated in combination with platinum-based chemotherapy plus pembrolizumab.
(8) Age on the date of enrollment is 20 years or older.
(9) Performance status is 0, 1, or 2 according to ECOG criteria.
(10) Weight is greater than 30 kg and less than 100 kg.
(11) Patients can be enrolled with or without measurable lesions.
(12) No symptomatic brain metastases, meningeal carcinomatosis, or spinal metastases requiring radiation therapy or surgery. However, patients may be enrolled after appropriate local treatment.
(13) Complications of autoimmune diseases can be registered at the discretion of the physician in charge, if they are controlled by appropriate treatment, regardless of the name of the disease.
(14) Patients do not have obvious interstitial pneumonia diagnosed by chest CT (however, a history of radiation pneumonitis or organizing radiation pneumonitis in the irradiated field is acceptable). The presence or absence of interstitial pneumonia can also be registered at the discretion of the physician in charge.
(15) Patients can be enrolled any organ functions (clinical laboratory test results).
However, when using cisplatin, carboplatin, pemetrexed, nab-paclitaxel, or paclitaxel, the appropriate organ function should be confirmed by referring to the package insert, respectively.
(16) Patients who are participating or will participate in other clinical trials or observational studies may participate in this study if they are allowed by those protocols.
(17) Written informed consent has been obtained from the patient.

Exclude criteria

Exclusion Criteria
(1) Have an infectious disease requiring systemic treatment.
(2) Women who are pregnant, have a desire to become pregnant, are within 28 days postpartum, or are breastfeeding.
(3) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in this study.
(4) Patients with diabetes mellitus, hypertension, congestive heart failure, unstable angina pectoris, serious arrhythmia, cerebrovascular disease, etc. that are poorly controlled by appropriate treatment and are judged by the attending physician to make participation in the study difficult.
(5) Co-occurrence of advanced multiple cancers that would affect the assessment of the primary endpoint.
(6) Other complications or pre-existing medical conditions that would preclude participation in this study.

Related Information

• Primary Sponsor: Kunito Hideo
• Source(s) of Monetary Support: Public Health Research Foundation