Phase II study of Revival of Platinum-doublet Chemotherapy in Advanced NSCLC patients Resistant to Combination Immunotherapy

JRCT ID: jRCTs061240065

Registered date:08/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 08/10/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Patients enrolled will receive the following treatment as specified by histology and prior therapy.
Non-squamous (Non-Sq) / previously treated with pemetrexed
Carboplatin (AUC=5, day 1) + nab-paclitaxel (100 mg/m2, day 1, 8, 15) every 3 weeks for 4 cycles. If no discontinuation criteria are met, nab-paclitaxel alone will be repeated on the same schedule until PD.
Non-Squamous (Non-Sq) / previously treated with paclitaxel or nab-paclitaxel
Carboplatin (AUC=5, day 1) + pemetrexed (500 mg/m2, day 1) every 3 weeks for 4 cycles. If no discontinuation criteria are met, pemetrexed alone will be repeated on the same schedule until PD.
Patients with squamous cell (Sq) / previously treated with paclitaxel or nab-paclitaxel
Carboplatin (AUC=5, day 1) + gemcitabine (1,000 mg/m2, day 1, 8) every 3 weeks for 4 cycles. If no discontinuation criteria are met, gemcitabine alone is repeated on the same schedule until PD.
Squamous cell (Sq) / previously treated with gemcitabine
Carboplatin (AUC=5, day 1) + nab-paclitaxel (100 mg/m2, day 1, 8, 15) every 3 weeks for 4 cycles. If no discontinuation criteria are met, nab-paclitaxel alone will be repeated on the same schedule until PD.

Outcome(s)

• Primary Outcome: Progression free survival

Secondary Outcome

1) Overall survival
2) Objective Response Rate
3) Toxicity (CTCAE ver 5.0)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) A definitive diagnosis of non-small cell lung cancer has been made by histology or cytology.
2) Patients must have received the following treatment regimens as initial therapy for at least 3 months (90 days) since the last administration.
Non-squamous non-small cell lung cancer
Cisplatin/carboplatin + pemetrexed + pembrolizumab
Carboplatin + paclitaxel + bevacizumab + atezolizumab
Carboplatin + nab-paclitaxel + atezolizumab
Cisplatin/carboplatin + pemetrexed + atezolizumab
Cisplatin/carboplatin + pemetrexed + nivolumab + ipilimumab
Cisplatin/carboplatin + pemetrexed + durvalumab + tremelimumab
Carboplatin + nab-paclitaxel + durvalumab + tremelimumab
Carboplatin + paclitaxel + bevacizumab + nivolumab
Squamous cell non-small cell lung cancer
Carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab
Carboplatin + paclitaxel + nivolumab + ipilimumab
Carboplatin + nab-paclitaxel + durvalumab + tremelimumab
Cisplatin/carboplatin + gemcitabine + durvalumab + tremelimumab
3) Patients with driver gene mutations (EGFR/ALK/ROS1/BRAF/RET/MET/KRASG12C/HER2/NTRK) have undergone targeted therapy and exacerbation as described in the guidelines for lung cancer treatment.
4) Age at the time of consent is 18 years or older.
5) Performance Status (ECOG) 0-1
6) Has measurable disease.
7) Latest laboratory values within 14 days prior to enrollment (same day of the week 2 weeks prior to enrollment is acceptable) meet all of the following criteria
1. White blood cell count > 3,000 /mm3 and neutrophil count > 1,500 /mm3
2. Hemoglobin < 9.0 g/dL
3. Platelet count > 100,000 /mm3
4. AST (GOT) < 100 IU/L
5. ALT (GPT) < 100 IU/L
6. Total bilirubin < 1.5 mg/dL
7. Serum creatinine < 1.5 mg/dL
8. SpO2 > 92% or PaO2 > 60 Torr at room air
8) The purpose and details of the study have been explained to the patient, and written consent has been obtained from the patient.

Exclude criteria

1) Patients with a history of allergy to platinum (cisplatin or carboplatin).
2) Patients with active interstitial pneumonia evident on chest X-ray.
3) Patients with serious cardiac or cerebrovascular disease, active peptic ulcer, fever over 38 degrees Celsius or serious infection, poorly controlled diabetes mellitus, or severe psychiatric or hearing disease.
4) Patients with symptomatic brain metastases. (Patients whose disease has been stabilized by local therapy or other means may be enrolled.)
5) Patients who have been disease-free for 3 years or less and have overlapping cancers that are considered to have a more clearly defined prognosis than lung cancer.
6) Patients with thoracoabdominal or pericardial effusions requiring repeated drainage (may be enrolled if the effusion becomes controllable).
7) Pregnant/lactating women or women who may or intend to become pregnant or men with such partners.
8) Patients requiring urgent radiotherapy.
9) Other patients deemed inappropriate by the physician in charge.

Related Information

• Primary Sponsor: Ninomiya Kiichiro