EGFR Activating MutationPhase 3NCT07897188
ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
A Phase 3 study testing ASKC202, osimertinib and pemetrexed in people with EGFR Activating Mutation and Non-Squamous Non-Small Cell Lung Cancer (NSCLC), run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Activating Mutation, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), MET Positive
- What is being tested?
- ASKC202, osimertinib and pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 20 Nov 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent.
- Male or female, at least 18 years of age at the time of ICF signing.
- Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, not amenable to curative surgery or radiotherapy.
- Patients must have untreated advanced NSCLC not amenable to curative surgery or radiotherapy. Prior adjuvant and neo-adjuvant therapies or definitive radiation/chemoradiation are permitted as long as treatment was completed at least 6 months prior to the development of recurrent disease.
- The tumor harbors EGFR sensitizing mutation (Ex19Del or L858R).
- MET protein overexpression as determined by central laboratory testing of tumor tissue samples.
Show all 10Show fewer
- At least one measurable lesion as assessed by RECIST v1.1.
- Have adequate organ functions.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have an estimated life expectancy ≥ 12 weeks.
Who cannot join
- Known coexistence of other oncogenic driver gene alterations.
- Prior therapy with an EGFR inhibitor (Patients who have completed the maximum permitted duration of adjuvant therapy and whose disease progressed or recurred ≥12 months after completion of such therapy are eligible for enrollment) or a c-MET-targeted inhibitor.
- Receipt of any other investigational agent within 4 weeks prior to the first dose of study treatment.
- Unresolved toxicity of CTCAE Grade ≥2 severity attributed to prior anti-tumor therapy at the time of first dose of study drug.
- Patients with symptomatic brain metastases or unstable brain metastases.
- Presence of leptomeningeal disease, brainstem metastases, or spinal cord compression.
Show all 9Show fewer
- Prior or concurrent malignancy other than study disease.
- Inability to swallow oral medication, or any gastrointestinal disease or condition that may significantly impair the absorption of the study drug.
- Any other serious or uncontrolled acute or chronic medical condition that, in the investigator's judgment, would render the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai East Hospital
Shanghai
Caicun Zhou, PHD, +86-21-65115006, caicunzhoudr@163.com
Caicun Zhou, PHD
About this study
Official title: A Randomized, Controlled, Double-Blind, Multicenter, Phase 3 Clinical Study of ASKC202 Plus Limertinib Versus Osimertinib for First-Line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLC
Read the detailed description
This is a randomized, controlled, multicenter, Phase 3 clinical study designed to evaluate the efficacy and safety of ASKC202 plus limertinib (double-blind Arm A) versus osimertinib (double-blind Arm B) as first-line treatment for patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR sensitizing mutations (19Del or 21 L858R) and MET protein overexpression. In addition, Arm C (open-label) will concurrently evaluate the efficacy and safety of osimertinib plus pemetrexed and cisplatin or carboplatin as first-line treatment for patients with EGFRm+/MET+ locally advanced or metastatic non-squamous NSCLC.
Eligible participants will be stratified by EGFR mutation status (19Del vs. L858R) and brain metastasis (yes vs. no) and randomly assigned in a 2:2:1 ratio to Arm A, Arm B, or Arm C. Participants in each arm will receive the corresponding study treatment (21-day cycle) until disease progression, death, intolerable toxicity, or fulfillment of any other protocol-defined treatment discontinuation criterion, whichever occurs first.
- Being tested
- ASKC202, ASKC202 placebo, osimertinib placebo, osimertinib, pemetrexed
- Keywords
- non-squamous NSCLC; MET inhibitor; EGFR inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASKC202Drug
ASKC202 tablets 200 mg QD
ASKC202 placeboDrug
ASKC202 placebo tablets QD
osimertinib placeboDrug
osimertinib placebo tablets QD
osimertinibDrug
osimertinib tablets 80 mg QD
pemetrexedDrug
pemetrexed 500 mg/m² by intravenous infusion on Day 1 of each 21-day cycle
cisplatin or carboplatinDrug
cisplatin 75 mg/m² or carboplatin (AUC 5) by intravenous infusion on Day 1 of each 21-day cycle for up to 4 cycles
LimertinibDrug
limertinib tablets 80 mg BID
limertinib placeboDrug
limertinib placebo tablets BID
| Study group | Role | What they receive |
|---|---|---|
| Arm A: ASKC202 + limertinib | Experimental | ASKC202 tablets 200 mg once daily (QD) + limertinib tablets 80 mg twice daily (BID) + osimertinib placebo tablets QD, orally Receives: Drug: ASKC202; Drug: osimertinib placebo; Drug: Limertinib |
| Arm B: osimertinib | Active comparator | Arm B: ASKC202 placebo tablets QD + limertinib placebo tablets BID + osimertinib tablets 80 mg QD, orally Receives: Drug: ASKC202 placebo; Drug: osimertinib; Drug: limertinib placebo |
| Arm C: osimertinib + pemetrexed + cisplatin or carboplatin | Other | Arm C: Osimertinib tablets 80 mg QD orally + pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin (AUC 5) by intravenous infusion on Day 1 of each 21-day cycle for up to 4 cycles; followed by maintenance therapy with osimertinib tablets 80 mg QD orally + pemetrexed 500 mg/m² by intravenous infusion on Day 1 of each 21-day cycle. Receives: Drug: osimertinib; Drug: pemetrexed; Drug: cisplatin or carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) by BICR
Progression-free survival (PFS) using BICR assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause (whichever occurred first).
Measured: 3 years
Secondary outcomes (6)
Progression-free survival (PFS) by investigator
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause (whichever occurred first).
Measured: 3 years
Overall Survival (OS)
The time from the date of randomization to the date of death.
Measured: 4 years
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR).
Measured: 3 years
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with complete response(CR), partial response(PR) and stable disease(SD).
Measured: 3 years
Duration of Response (DoR)
Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression or death.
Measured: 3 years
Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as recorded on the case report form NCI CTCAE v6.0.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion20 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Activating MutationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897188
- Sponsor's protocol ID
- ASKC202-302
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-Blind, Multicenter, Phase 3 Clinical Study of ASKC202 Plus Limertinib Versus Osimertinib for First-Line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT07897188
- Acronym / sponsor ID
- ASKC202-302
- Keywords
- non-squamous NSCLC; MET inhibitor; EGFR inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 20 Nov 2032 (estimated)
- First posted
- 27 Oct 2026 (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.
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLC
Detailed description
This is a randomized, controlled, multicenter, Phase 3 clinical study designed to evaluate the efficacy and safety of ASKC202 plus limertinib (double-blind Arm A) versus osimertinib (double-blind Arm B) as first-line treatment for patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR sensitizing mutations (19Del or 21 L858R) and MET protein overexpression. In addition, Arm C (open-label) will concurrently evaluate the efficacy and safety of osimertinib plus pemetrexed and cisplatin or carboplatin as first-line treatment for patients with EGFRm+/MET+ locally advanced or metastatic non-squamous NSCLC.
Eligible participants will be stratified by EGFR mutation status (19Del vs. L858R) and brain metastasis (yes vs. no) and randomly assigned in a 2:2:1 ratio to Arm A, Arm B, or Arm C. Participants in each arm will receive the corresponding study treatment (21-day cycle) until disease progression, death, intolerable toxicity, or fulfillment of any other protocol-defined treatment discontinuation criterion, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: ASKC202 + limertinib | Experimental | Drug: ASKC202, Drug: osimertinib placebo, Drug: LimertinibASKC202 tablets 200 mg once daily (QD) + limertinib tablets 80 mg twice daily (BID) + osimertinib placebo tablets QD, orally |
| Arm B: osimertinib | Active comparator | Drug: ASKC202 placebo, Drug: osimertinib, Drug: limertinib placeboArm B: ASKC202 placebo tablets QD + limertinib placebo tablets BID + osimertinib tablets 80 mg QD, orally |
| Arm C: osimertinib + pemetrexed + cisplatin or carboplatin | Other | Drug: osimertinib, Drug: pemetrexed, Drug: cisplatin or carboplatinArm C: Osimertinib tablets 80 mg QD orally + pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin (AUC 5) by intravenous infusion on Day 1 of each 21-day cycle for up to 4 cycles; followed by maintenance therapy with osimertinib tablets 80 mg QD orally + pemetrexed 500 mg/m² by intravenous infusion on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Capable of giving signed informed consent.
- Male or female, at least 18 years of age at the time of ICF signing.
- Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, not amenable to curative surgery or radiotherapy.
- Patients must have untreated advanced NSCLC not amenable to curative surgery or radiotherapy. Prior adjuvant and neo-adjuvant therapies or definitive radiation/chemoradiation are permitted as long as treatment was completed at least 6 months prior to the development of recurrent disease.
- The tumor harbors EGFR sensitizing mutation (Ex19Del or L858R).
Key exclusion criteria (9 listed)
- Known coexistence of other oncogenic driver gene alterations.
- Prior therapy with an EGFR inhibitor (Patients who have completed the maximum permitted duration of adjuvant therapy and whose disease progressed or recurred ≥12 months after completion of such therapy are eligible for enrollment) or a c-MET-targeted inhibitor.
- Receipt of any other investigational agent within 4 weeks prior to the first dose of study treatment.
- Unresolved toxicity of CTCAE Grade ≥2 severity attributed to prior anti-tumor therapy at the time of first dose of study drug.
- Patients with symptomatic brain metastases or unstable brain metastases.
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 |
|---|---|---|
| ASKC202ASKC202 tablets 200 mg QD | Drug | Arm A: ASKC202 + limertinib |
| ASKC202 placeboASKC202 placebo tablets QD | Drug | Arm B: osimertinib |
| osimertinib placeboosimertinib placebo tablets QD | Drug | Arm A: ASKC202 + limertinib |
| osimertinibosimertinib tablets 80 mg QD | Drug | Arm B: osimertinib, Arm C: osimertinib + pemetrexed + cisplatin or carboplatin |
| pemetrexedpemetrexed 500 mg/m² by intravenous infusion on Day 1 of each 21-day cycle | Drug | Arm C: osimertinib + pemetrexed + cisplatin or carboplatin |
| cisplatin or carboplatincisplatin 75 mg/m² or carboplatin (AUC 5) by intravenous infusion on Day 1 of each 21-day cycle for up to 4 cycles | Drug | Arm C: osimertinib + pemetrexed + cisplatin or carboplatin |
| Limertiniblimertinib tablets 80 mg BID | Drug | Arm A: ASKC202 + limertinib |
| limertinib placebolimertinib placebo tablets BID | Drug | Arm B: osimertinib |
Primary outcome
Progression-Free Survival (PFS) by BICR
Time frame: 3 years
Progression-free survival (PFS) using BICR assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause (whichever occurred first).
6 secondary outcomes
Progression-free survival (PFS) by investigator
Time frame: 3 years
Overall Survival (OS)
Time frame: 4 years
Objective Response Rate (ORR)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Duration of Response (DoR)
Time frame: 3 years
Incidence and severity of treatment-emergent adverse events
Time frame: 3 years
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 27 Oct 2026.
Related trials for EGFR Activating Mutation
RecruitingPhase 3
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Non-small Cell Lung Cancer, HER2 Mutation
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 1/2
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
NSCLC (Advanced Non-small Cell Lung Cancer)
RecruitingPhase 3
Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations
Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer
RecruitingPhase 2
Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases
Non-Small Cell Lung Cancer, Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASKC202, osimertinib and pemetrexed in people with EGFR Activating Mutation and Non-Squamous Non-Small Cell Lung Cancer (NSCLC), run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site 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 9 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jiangsu Aosaikang Study Director (+86 025 52169999, ctr-contact@ask-pharm.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) by BICR (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.