Health TrialsbyHealthPanel

Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC

ConditionLocal Advanced or Metastatic NSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

This study is aimed to evaluate the efficacy and safety of the Garsorasib combination therapy in KRAS G12C mutant locally advanced and metastatic NSCLC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Neutrophil count≥1.5×109/L,

Platelet count≥90×109/L,

Hemoglobin≥90g/L

Serum creatinine≤1.5×upper limit of normal (ULN), creatinine clearance≥50 mL/min (Cockcroft-Gault formula)

Disqualifiers

NYHA (New York Heart Association) Class 3 and 4 congestive heart failure

Arrhythmia requiring therapeutic intervention

Thrombotic or embolic event within the past 6 months, e.g., cerebrovascular accident (including transient ischemic attack), and pulmonary embolism

LVEF<50%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Garsorasib, Benmelstobart, Anlotinib

    Drug

    Cohort1: Garsorasib RP2D QD D1-21, Benmelstobart 1200 mg IV D1, q21d, Anlotinib 8mg QD, D1-14,q21d. N1=20 participants.

  • Benmelstobart, Anlotinib

    Drug

    Benmelstobart 1200 mg IV D1, q21d, Anlotinib 8mg QD, D1-14,q21d. N2=20 participants.

  • Garsorasib, Cetuximab Beta Injection

    Drug

    Garsorasib 600mg BID, D1, q14d, Cetuximab Beta Injection 500mg/㎡ IV, q14d. N3=20 participants

Treatment groups

69 Participants
are divided into 3 treatment groups
Group A: Cohort1: PD-L1≧1%, Garsorasib+Benmelstobart+AnlotinibExperimental treatment 1 intervention
Group B: Cohort2: PD-L1≧1%, Benmelstobart+AnlotinibExperimental treatment 1 intervention
Group C: Cohort3: PD-L1<1%, Garsorasib+Cetuximab Beta InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).

Time frame
up to 180 days
2

DoR

DoR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.

Time frame
up to 180 days

Secondary outcomes

1

PFS

defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Time frame
up to 180 days
2

DCR

Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease(SD).

Time frame
up to 180 days
3

TTR

TTR was defined as Time from Randomization to First Response According to RECIST 1.1 Criteria

Time frame
up to 180 days.
4

OS

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

Time frame
up to 360 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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