Non-Small Cell Lung CancerPhase 3NCT07174908
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
A Phase 3 study testing IN10018 in combination with D-1553 and anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed in people with Non-Small Cell Lung Cancer, run by InxMed (Shanghai) Co., Ltd. at 11 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- IN10018 in combination with D-1553 and anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 11 sitesChina
- Study dates
- 10 Sep 2025to Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ECOG performance status of 0-1
- Has adequate organ function
- Life expectancy ≥3 months in the opinion of the Investigator
- Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment
Who cannot join
- 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)
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- 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 interventional clinical study
- Any condition that, in the opinion of the Investigator, would interfere with participation or study results
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jack Zhang Clinical Trial Manager, bachelor contact
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Zhao Chief Physician, MD, 86-13521469355, ohJerry@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Yongzhong Luo Chief Physician, MD, 86-13607443876, luoyongzhong@hnca.org.cn
- Not yet recruiting
First Affiliated Hospital of Gannan Medical University
Gannan, Jiangxi
Huaqiu Shi Chief Physician, BS, 86-13576666365, shq3677274@163.com
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Kejing Tang Chief Physician, MD, 86-13802946566, tangkj@mail.sysu.edu.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Zhengbo Song Chief Physician, MD, 86-13857153345, songzb@zjcc.org.cn
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Longhua Sun Chief Physician, MD, 86-18279110112, sunlonghua012024@163.com
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Bo Shen Chief Physician, MD, 86-13913910555, shenbo987@126.com
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Shun Lu Chief Physician, MD, 86-13857153345, shun_lu@hotmail.com
Yongfeng Yu Chief Physician, MD
- Recruiting
Union Hospital Tongji Medidcal College Huazhong University of Science and Technology
Wuhan, Hubei
Ruiguang Zhang Associate Chief Physician, MD, 86-15071116896, zrg27@163.com
Xiaorong Dong Chief Physician, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Huijuan Wang Chief Physician, MD, 86-18638561588, 18638561588@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Sanxing Guo Chief Physician, MD, 86-18337128112, sanxing134@hotmail.com
About this study
Official title: A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
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).
Read the detailed description
Preclinical studies indicate that IN10018 synergizes with D-1553 to enhance antitumor activity and delay resistance through multiple mechanisms, including suppression of FAK-YAP signaling pathway activation, reduction of tumor stromal fibrosis, and induction of immunogenic cell death (ICD). IN10018-602/D1553-106 is an ongoing Phase Ib/II clinical study evaluating the synergistic antitumor activity and safety of IN10018 combined with D-1553 in patients with KRAS G12C-mutant solid tumors. Preliminary results have demonstrated notable antitumor activity and a favorable safety and tolerability profile in patients with advanced KRAS G12C-mutant NSCLC and metastatic colorectal cancer. Based on the available clinical data, the sponsor plans to initiate a Phase III study in previously untreated patients with advanced KRAS G12C-mutant NSCLC to further evaluate the efficacy and safety of IN10018 in combination with D-1553 compared with first-line standard treatment.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- IN10018 in combination with D-1553, anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN10018 in combination with D-1553Drug
IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle
anti-PD-1 monoclonal antibody in combination with platinum and pemetrexedDrug
Tislelizumab 200mg Q3W IV + Carboplatin AUC 5 mg/mL/min or Cisplatin 75mg/m² Q3W IV+ Pemetrexed 500mg/m² Q3W IV
| Study group | Role | What they receive |
|---|---|---|
| IN10018 plus D-1553 | Experimental | Subjects receive IN10018 100mg orally once daily (QD) and D-1553 600mg orally twice daily (BID) on Days 1-21 of each 21-day cycle, until disease progression or unacceptable toxicity. Receives: Drug: IN10018 in combination with D-1553 |
| Tislelizumab plus Platinum and Pemetrexed | Active comparator | Subjects receive Tislelizumab 200mg intravenously (IV) once every 3 weeks (Q3W) until disease progression, plus Carboplatin (AUC = 5 mg/mL/min, Q3W, IV) or Cisplatin (75 mg/m², Q3W, IV) for up to 4 cycles, in combination with Pemetrexed (500 mg/m², Q3W, IV) until disease progression. Receives: Drug: anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).
Measured: up to 36 months
Secondary outcomes (9)
Objective Response Rate (ORR)
Defined as complete response (PR) + partial response (PR) assessed per RECIST v1.1 by BICR
Measured: up to 36 months
Overall Survival (OS)
Defined as time from randomization to death by any cause
Measured: up to 60 months
Disease Control Rate (DCR)
Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by BICR
Measured: Up to 36 months
Duration of Response (DoR)
Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first. assessed per RECIST v1.1 by BICR
Measured: up to 36 months
PFS
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by investigator assessment.
Measured: up to 36 months
ORR
defined as CR+PR assessed per RECIST v1.1 by investigators
Measured: up to 36 months
DCR
Defined as ORR + stable disease (SD) assessed per RECIST v1.1 by investigators
Measured: up to 36 months
DOR
Defined as time from first evidence of PR or CR to disease progression or death due to any cause, whichever occurs first. assessed per RECIST v1.1 by investigators
Measured: Up to 36 months
Number of subjects with adverse event
The number of subjects who experienced AEs is presented
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start10 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhengbo Song Professor, Doctor, Principal investigator, Zhejiang Cancer HospitalShun Lu Professor, Doctor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174908
- Sponsor's protocol ID
- IN10018-023
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song Z, Li X, Lin R, Shi H, Yuan Y, Liu Y, Luo Y, Lv T, Zhang Y, Zhu L, Zhu Y, Zhang L, Wang Z. Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. Lancet Respir Med. 2026 Jul 7:S2213-2600(26)00142-6. doi: 10.1016/S2213-2600(26)00142-6. Online ahead of print.
PubMed 42413526
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Controlled, and Open-Label Study of IN10018 in Combination With D-1553 Versus Standard Therapy for the Treatment of First Line Locally-advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT07174908
- Acronym / sponsor ID
- IN10018-023
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Preclinical studies indicate that IN10018 synergizes with D-1553 to enhance antitumor activity and delay resistance through multiple mechanisms, including suppression of FAK-YAP signaling pathway activation, reduction of tumor stromal fibrosis, and induction of immunogenic cell death (ICD). IN10018-602/D1553-106 is an ongoing Phase Ib/II clinical study evaluating the synergistic antitumor activity and safety of IN10018 combined with D-1553 in patients with KRAS G12C-mutant solid tumors. Preliminary results have demonstrated notable antitumor activity and a favorable safety and tolerability profile in patients with advanced KRAS G12C-mutant NSCLC and metastatic colorectal cancer. Based on the available clinical data, the sponsor plans to initiate a Phase III study in previously untreated patients with advanced KRAS G12C-mutant NSCLC to further evaluate the efficacy and safety of IN10018 in combination with D-1553 compared with first-line standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN10018 plus D-1553 | Experimental | Drug: IN10018 in combination with D-1553Subjects receive IN10018 100mg orally once daily (QD) and D-1553 600mg orally twice daily (BID) on Days 1-21 of each 21-day cycle, until disease progression or unacceptable toxicity. |
| Tislelizumab plus Platinum and Pemetrexed | Active comparator | Drug: anti-PD-1 monoclonal antibody in combination with platinum and pemetrexedSubjects receive Tislelizumab 200mg intravenously (IV) once every 3 weeks (Q3W) until disease progression, plus Carboplatin (AUC = 5 mg/mL/min, Q3W, IV) or Cisplatin (75 mg/m², Q3W, IV) for up to 4 cycles, in combination with Pemetrexed (500 mg/m², Q3W, IV) until disease progression. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN10018 in combination with D-1553IN10018 100mg QD PO and D-1553 600mg BID PO, 21days per cycle | Drug | IN10018 plus D-1553 |
| anti-PD-1 monoclonal antibody in combination with platinum and pemetrexedTislelizumab 200mg Q3W IV + Carboplatin AUC 5 mg/mL/min or Cisplatin 75mg/m² Q3W IV+ Pemetrexed 500mg/m² Q3W IV | Drug | Tislelizumab plus Platinum and Pemetrexed |
Primary outcome
Progression-Free Survival (PFS)
Time frame: up to 36 months
Defined as time from randomization until disease progression or death from any cause, whichever occurs first assessed per RECIST v1.1 by blinded independent central review (BICR).
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 36 months
Overall Survival (OS)
Time frame: up to 60 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Duration of Response (DoR)
Time frame: up to 36 months
PFS
Time frame: up to 36 months
ORR
Time frame: up to 36 months
DCR
Time frame: up to 36 months
DOR
Time frame: Up to 36 months
Number of subjects with adverse event
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Derived from this study: PubMed 42413526Song Z, Li X, Lin R, Shi H, Yuan Y, Liu Y, Luo Y, Lv T, Zhang Y, Zhu L, Zhu Y, Zhang L, Wang Z. Ifebemtinib plus garsorasib as first-line treatment for KRASG12C-mutated non-small-cell lung cancer in China: a multicentre, single-arm expansion cohort from a phase 1b/2 trial. Lancet Respir Med. 2026 Jul 7:S2213-2600(26)00142-6. doi: 10.1016/S2213-2600(26)00142-6. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jack Zhang Clinical Trial Manager, bachelor contact
Zhengbo Song Professor, Doctor principal investigator
Zhejiang Cancer Hospital
Shun Lu Professor, Doctor principal investigator
Shanghai Chest Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IN10018 in combination with D-1553 and anti-PD-1 monoclonal antibody in combination with platinum and pemetrexed in people with Non-Small Cell Lung Cancer, run by InxMed (Shanghai) Co., Ltd. at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu Fang Project Manager, bachelor (86-15933968623, shu.fang@inxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.