AK112 Plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC

ConditionEfficacy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHunan Province Tumor Hospital

About this trial

The investigators want to evaluated the Efficay and Satety of PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR/ALK/ROS1 Positve NSCLC who Failed from First-Line Standard Treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign written informed consent before implementing any trial-related procedures;

Age ≥18 years old and ≤75 years old;

No limit on the gender;

The ECOG score is 0 or 1.

Disqualifiers

Histological or cytological pathology confirmed the presence of a small cell carcinoma component, or a squamous cell carcinoma as a major component

Patients who have received immunotherapy previously, including immune checkpoint inhibitors (such as anti-PD-1/L1, anti-CTLA-4 , anti-LAG-3, etc.), immune checkpoint activators (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy and any other treatment targeting the immunity mechanism.

Previously received other anti-tumor therapy for advanced stages of NSCLC (stages IIIB to IV) (including cytotoxic chemotherapy used with radiotherapy, systemic chemotherapy, and anti-VEGFR therapy) .

Concurrent enrollment in another clinical trial is allowed, unless it involves a non-interventional clinical study or the follow-up period of an interventional study (defined as the time elapsed from the initiation of the first drug to at least 4 weeks after the last drug administration in the previous clinical study or beyond 5 half-lives of the investigational drug in that study, whichever is shorter).

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy

    Drug

    PD-1/VEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Cohort of EGFR Sensitve Mutant NSCLCExperimental treatment 1 intervention
Group B: Cohort of ALK Fusion NSCLCExperimental treatment 1 intervention
Group C: Cohort of ROS1 Fusion NSCLCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RP2D

We want to evaluate the best dose for treatment.

Time frame
2 months
2

ORR

Overall response rate

Time frame
12 months
3

PFS

Progression free survival time

Time frame
12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: