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Compares treatment options for Non-Small Cell Lung Cancer
Official title A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
ClinicalTrials.gov ID: NCT07174908
What this study is testing
What is IN10018 in combination with D-1553?
IN10018 in combination with D-1553 is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, open-label, phase III clinical study, to evaluate the efficacy and safety of IN10018 in combination with D-1553 as compared to anti-PD-1 monoclonal antibody (mAb) in combination with platinum and pemetrexed as the first-line treatment for the locally advanced or metastatic KRASG12C mutation-positive non-squamous non-small cell lung cancer (NSCLC).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Able and willing to provide informed consent and comply with study requirements
- Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
- Aged 18-80 years at the time of consent
- Has KRAS G12C mutation confirmed by central laboratory
- Has not received prior systemic therapy for advanced or metastatic NSCLC
You likely can't join if
- Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)
- Has active or untreated CNS metastases or carcinomatous meningitis
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors
- Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)
- Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy
- Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical...
See the full eligibility criteria
- Able and willing to provide informed consent and comply with study requirements
- Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
- Aged 18-80 years at the time of consent
- Has KRAS G12C mutation confirmed by central laboratory
- Has not received prior systemic therapy for advanced or metastatic NSCLC
- Has at least one measurable lesion per RECIST v1.1
- ECOG performance status of 0-1
- Has adequate organ function
- Life expectancy ≥3 months in the opinion of the Investigator
- Male and female people of reproductive potential must agree to use effective contraception during and for 6 months after treatment
- Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)
- Has active or untreated CNS metastases or carcinomatous meningitis
- Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors
- Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)
- Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy
- Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ)
- Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable)
- Has known active hepatitis B, hepatitis C, or HIV infection
- Has received a live vaccine within 30 days before first dose of study drug
- Pregnant or breastfeeding women
- Has psychiatric or substance abuse disorders that would interfere with study compliance
- Is participating in another treatment clinical study
- Any condition that, in the opinion of the Investigator, would interfere with participation or study results
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Gannan, Jiangxi, China
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China; Nanjing, Jiangsu, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.