Phase II study of chemotheraphy and ICI for elderly patients with advanced non-squamous cell lung cancer

JRCT ID: jRCTs051190095

Registered date:17/01/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: advanced non-squamous cell lung cancer
• Date of first enrollment: 22/04/2020
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Carboplatine (AUC5), pemetrexed(500mg/m2) and pembrolizumab(200mg/body) are administered by infusion every 3 weeks until 4 courses or the protocol treatment discontinuation criteria are met. After 4 courses, as maintenance therapy, pemetrexed(500mg/m2) and pembrolizumab(200mg/body) are administered by infusion every 3 weeks until the protocol treatment discontinuation criteria are met.

Outcome(s)

• Primary Outcome: overall response rate/ORR

Secondary Outcome

Disease control rate/DCR
Progression free survival/PFS
Overall survival/OS
Duration of response
6m PFS
1y survival rate
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Has a histologically-confirmed or cytologically confirmed diagnosis of stage 3B, 3C or 4 of difficulgies with radical irradiation or postoperative recurrence non-squamous NSCLC
2. Documented absence or unknown of tumor activating EGFR mutations AND absence of ALK gene rearrangements
3. Documented absence or unknown of tumor activating ROS-1 mutations AND absence of tumor activating BRAF-V600E mutation
4. Has not received prior systemic treatment for their advanced/metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
5. Be >=75 years of age
6. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
7. Has adequate organ function
8. Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
9. Has a life expectancy of at least 3 months.
10. Subject has voluntarily agreed to participate by giving written informed consent for the trial.

Exclude criteria

1. Has interstitial lung disease or a history of pneumonitis
2. Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment.
3. Completedpalliative radiotherapy within 7 days of the first dose of trial treatment.
4. Has known symptomatic central nervous system (CNS) metastases
5. Has active double cancers (within 2 years)
6.Has known active Hepatitis B or C.
7. Has known history o f Human Immunodeficiency Virus (HIV)
8. Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
9. Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose <= 1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
10. Has active autoimmune disease that has required systemic treatment (i.e. with use of disease modifying agents, corticosteroids up to 10 mg of prednisone, or immunosuppressive drugs).
11. Has known sensitivity to any component of cisplatin, carboplatin or pemetrexed
12. Is unable or unwilling to take folic acid or vitamin B12 supplementation.
13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is otherwise not in the the best interest of the subject to participate, in the opinion of the treating Investigator.

Related Information

• Primary Sponsor: Kanai Kuninobu