Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment

Conditions

• Stage III NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  The IP will be given to the patient as long as there is a clinical benefit, in invertigator's judgment. Per day, 1500 mg
• Tremelimumab — DRUG
  Per day 75mg
• Pemetrexed — DRUG
  500 mg/m2 on day 1 every 3 weeks for 2 cycles
• Cisplatin — DRUG
  6 mg / m2 on day 1 every 3 weeks for 2 cycles
• chemo radiotherapy — RADIATION
  Once-daily fraction, 2 Gy per fraction. Total dose is 60 Gy.
• Resection — PROCEDURE
  After CIT-CRT

Study Details

A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy in the treatment of locally advanced NSCLC.

Key Dates

Start date

Dec 28, 2018

Status verified

Nov 2024

Primary completion

Nov 4, 2024

Completion

Nov 4, 2024

Study Design

Enrollment

18 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1A (firste cohort)
  1 course Durvalumab (1500mg) + Tremelimumab (75mg) + 1 course of Durvalumab (1500mg) followed by CRT
• Experimental: Cohort 2A
  2 course Durvalumab (1500mg) + Tremelimumab (75mg) followed by CRT
• Active Comparator: Cohort 2B
  2 course Durvalumab (1500mg) + Tremelimumab (75mg) followed by CRT

Primary Outcome Measure

Safety of CIT-induction with Tremelimumab and Durvalumab prior to CRT in stage III NSCLC [ Time Frame: 3 months after the last radiation dose. ]