A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ID
NCT06412471
Phase
PHASE2
Status
Unknown

Conditions

  • First-line Advanced NSCLC Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SSGJ-707 — DRUG
    bispecific antibody
  • carboplatin — DRUG
    chemotherapy
  • Pemetrexed — DRUG
    chemotherapy
  • paclitaxel — DRUG
    chemotherapy
  • PD-1/L1 — DRUG
    Immune checkpoint inhibitors
  • Paclitaxel-albumin — DRUG
    chemotherapy

Study Details

This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.

Key Dates

Start date
Jul 26, 2024
Status verified
May 2024
Primary completion
Jul 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
235 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    dose level 1 of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 2
    dose level 2 of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 3
    dose level 3 of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 4
    PD-1/L1 combined with chemotherapy
  • Experimental: Arm 5
    dose level 1 of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 6
    dose level 2 of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 7
    dose level 3 of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 8
    Selected dose of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 9
    Selected dose of SSGJ-707 combined with chemotherapy
  • Experimental: Arm 10
    PD-1/L1 combined with chemotherapy

Primary Outcome Measure

ORR [ Time Frame: 12 months ]

Central Contacts