A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients

Conditions

• Advanced Non Squamous NSCLC
• Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• roginolisib — DRUG
  tablet, 40mg tablet strength
• Dostarlimab — DRUG
  500 mg administered as IV infusion
• Docetaxel — DRUG
  75 mg/m2 administered over 1 hour as IV infusion

Study Details

The goal of this clinical trial is to learn how roginolisib works in combination with dostarlimab with or without docetaxel in adult patients with advanced non small-cell lung cancer. The main questions it aims to answer are: To compare across the treatment arms the proportion of patients with a reduction in Treg cells To evaluate the safety and tolerability of roginolisib plus dostarlimab, with or without docetaxel

Key Dates

Start date

Apr 22, 2025

Status verified

Jan 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Roginolisib + dostarlimab + docetaxel
  IOA-244 80 mg (corresponding to 72 mg roginolisib) once daily oral dosing on a 21-day cycle. Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. Docetaxel: 75 mg/m2 administered over 1 hour as IV infusion on Day 1 of every 21-day cycle.
• Experimental: Arm 2: Roginolisib + dostarlimab
  IOA-244 80 mg (corresponding to 72 mg roginolisib) once daily oral dosing on a 21-day cycle. Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles.
• Active Comparator: Arm 3: Dostarlimab + docetaxel
  Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. Docetaxel: 75 mg/m2 administered over 1 hour as IV infusion on Day 1 of every 21-day cycle.

Primary Outcome Measure

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE V5 [ Time Frame: On Day 1 and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days ]