A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
NCT ID: NCT06412471
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
235 participants
INTERVENTIONAL
2024-07-26
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
dose level 1 of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
Pemetrexed
chemotherapy
Arm 2
dose level 2 of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
Pemetrexed
chemotherapy
Arm 3
dose level 3 of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
Pemetrexed
chemotherapy
Arm 4
PD-1/L1 combined with chemotherapy
carboplatin
chemotherapy
Pemetrexed
chemotherapy
PD-1/L1
Immune checkpoint inhibitors
Arm 5
dose level 1 of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
paclitaxel
chemotherapy
Arm 6
dose level 2 of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
paclitaxel
chemotherapy
Arm 7
dose level 3 of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
paclitaxel
chemotherapy
Arm 8
Selected dose of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
paclitaxel
chemotherapy
Arm 9
Selected dose of SSGJ-707 combined with chemotherapy
SSGJ-707
bispecific antibody
carboplatin
chemotherapy
Paclitaxel-albumin
chemotherapy
Arm 10
PD-1/L1 combined with chemotherapy
carboplatin
chemotherapy
paclitaxel
chemotherapy
PD-1/L1
Immune checkpoint inhibitors
Interventions
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SSGJ-707
bispecific antibody
carboplatin
chemotherapy
Pemetrexed
chemotherapy
paclitaxel
chemotherapy
PD-1/L1
Immune checkpoint inhibitors
Paclitaxel-albumin
chemotherapy
Eligibility Criteria
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Inclusion Criteria
2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.
Exclusion Criteria
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
75 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Institute of The Hunan Cancer Hospital
Changsha, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SSGJ-707-NSCLC-II-02
Identifier Type: -
Identifier Source: org_study_id
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