NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2NCT07603791
Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.
A Phase 2 study testing ALK202 for injection, Osimertinib Mesylate Tablets and Ivonescimab Injection in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Shanghai Allink Biotherapeutics Co., Ltd..
Trial summary
This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- ALK202 for injection, Osimertinib Mesylate Tablets and Ivonescimab Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Dec 2028
- Phase
- Phase 2
- 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
- The trial Participants themselves (and/or guardians) have understood and agreed to follow the study procedures and voluntarily signed the ICF;
- Men and women ≥18 and ≤75 years old on the day of signing the ICF;
- The trial participants agree to provide fresh or archived tumor tissues for the detection of the expression status of driving genes or proteins (such as EGFR expression, c-MET expression, and PD-L1 expression status, etc.). If the trial participants are unable to provide the required tumor tissues for testing, their participation in the trial must be approved by the sponsor;
- The presence of at least one measurable lesion is required according to the RECIST v1.1 criteria. A neoplastic lesion that has received local treatment, such as radiotherapy, can be taken as a target lesion if disease progression is proved by imaging;
- Expected survival ≥ 3 months;
Who cannot join
- Previously received EGFR- and/or MET-targeting ADCs and/or ADCs with topoisomerase I inhibitor as the payload;
- Participated in other interventional clinical trials within 4 weeks or 5 drug half-lives before the first dose of ALK202 (whichever is shorter). Note: Patients who have participated in another interventional clinical trial, even if they are still in the survival follow-up period of the previous trial, may be enrolled in this study provided that the first dose of ALK202 is to be administered ≥5 half-lives or 4 weeks from the last dose of the trial drug (whichever is shorter);
- Received chemotherapy, targeted therapy, immunotherapy, interventional procedure, or other systemic antitumor therapy within 4 weeks (Note: 6 weeks for nitrosourea or mitomycin C, 2 weeks or 5 half-lives of the drugs [whichever is shorter] for oral fluorouracil and small-molecule targeted drugs, and 2 weeks for Chinese medicines with anti-tumor indications) prior to the first dose of ALK202;
- Received radical radiotherapy, whole-brain radiotherapy, or bone marrow irradiation > 30% within 4 weeks before the first dose of ALK202; or palliative radiation (including stereotactic radiotherapy) of non-target lesions for symptom relief purposes within 2 weeks prior to the first dose;
- Took drugs or food that strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4 within 2 weeks or within 5 half-lives prior to the first dose of ALK202, whichever is longer.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open, Multicenter Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Different Drugs in NSCLC Participants.
This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension).
Phase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen.
Read more
The Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets.
The Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection.
The Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection.
Phase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety.
Extension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression < 1% and high c-MET expression that has not received systemic treatment.
Read the detailed description
This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension).
Phase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen.
The Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets.
The Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection.
The Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection.
Phase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety.
Extension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression < 1% and high c-MET expression that has not received systemic treatment.
Expansion cohort 1: two groups participants treated with ALK202 at two different doses in combination with Osimertinib Mesylate Tablets. Eachdose group enrolled 30 trial participants, totaling 60 participants, and they are randomly assigned in a 1:1 ratio. The ALK202 treatment regimen involves intravenous infusion, on Day 1 or on Days 1 and 8, every 3 weeks or twice, until disease progression, intolerability, or death occurs. The Osimertinib Mesylate Tablets treatment regimen is 80 mg, orally, once daily, until disease progression, intolerability, or death.
Expansion cohort 2: two groups participants treated with ALK202 at two different doses in combination with Ivonescimab Injection. Each dose group includes 30 participants, totaling 60 participants, and they are randomly assigned in a 1:1 ratio. The ALK202 treatment regimen involves intravenous infusion, on Day 1 or on Days 1 and 8, every 3 weeks or twice. Until the disease progresses or becomes intolerable or leads to death; the Ivonescimab Injection treatment regimen is 20 mg/kg, administered intravenously, once every 3 weeks, until the disease progresses or becomes intolerable or leads to death.
Expansion cohort 3: participants will select two dosing regimens from the two-drug combination of ALK202+Ivonescimab Injection or the three-drug combination of ALK202 +Ivonescimab Injection+ Carboplatin for exploration based on the preliminary safety and efficacy results of ascending cohort 2 and ascending cohort 3.
- Being tested
- ALK202 for injection, Osimertinib Mesylate Tablets, Ivonescimab Injection, carboplatin injection
- Keywords
- NSCLC
- 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.
ALK202 for injectionDrug
This study employs combined medication. The participants in different groups are treated for non-small cell lung cancer using ALK202 in combination with various drugs.
Osimertinib Mesylate TabletsCombination product
Combination Drug 1: Osimertinib Mesylate Tablets, ALK202 combine with Osimertinib Mesylate Tablets for cohort1 enrolled participants
Ivonescimab InjectionCombination product
Combination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection for cohort2 enrolled participants
carboplatin injectionCombination product
Combination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection and carboplatin injection for cohort3 enrolled participants
| Study group | Role | What they receive |
|---|---|---|
| cohort1 | Experimental | Participants with Non-squamous NSCLC with EGFR mutation that has not received systemic palliative treatment, using the ALK202 combine with the Osimertinib Mesylate Tablets treatment Receives: Drug: ALK202 for injection; Combination Product: Osimertinib Mesylate Tablets |
| cohort2 | Experimental | Participants with NSCLC (non-small cell lung cancer) who have not received systemic palliative treatment, with PD-L1 expression ≥ 1% and high c-MET expression, and without any driver gene mutations; using the ALK202 combine with the Ivonescimab Injection treatment Receives: Drug: ALK202 for injection; Combination Product: Ivonescimab Injection |
| cohort3 | Experimental | Participants with NSCLC (non-small cell lung cancer) who have not received systemic palliative treatment, with PD-L1 expression < 1% and high c-MET expression, and without any driver gene mutations; using the ALK202 combine with the Ivonescimab Injection and carboplatin injection treatment Receives: Drug: ALK202 for injection; Combination Product: Ivonescimab Injection; Combination Product: carboplatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Measured: Up to 12 months
Secondary outcomes (6)
Peak Plasma Concentration (Cmax)
PK parameters after single andmultiple doses
Measured: Up to 12 months
ADAs
The generation of anti-drug antibodies
Measured: Up to 12 months
Area under the plasma concentration versus time curve (AUC)
PK parameters after single andmultiple doses
Measured: up to 12 months
Objective Response Rate(ORR)
Objective Response Rate(ORR) calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria
Measured: Up to 12 months
Disease Control Rate (DCR)
DCR calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria
Measured: Up to 12 months
Progression-FreeSurvival (PFS)
PFS calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603791
- Sponsor's protocol ID
- ALK202-02
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Different Drugs in NSCLC Participants.
- ClinicalTrials.gov ID
- NCT07603791
- Acronym / sponsor ID
- ALK202-02
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 May 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.
This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension).
Phase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen.
The Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets.
The Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection.
The Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection.
Phase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety.
Extension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression < 1% and high c-MET expression that has not received systemic treatment.
Detailed description
This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension).
Phase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen.
The Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets.
The Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection.
The Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection.
Phase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety.
Extension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression < 1% and high c-MET expression that has not received systemic treatment.
Expansion cohort 1: two groups participants treated with ALK202 at two different doses in combination with Osimertinib Mesylate Tablets. Eachdose group enrolled 30 trial participants, totaling 60 participants, and they are randomly assigned in a 1:1 ratio. The ALK202 treatment regimen involves intravenous infusion, on Day 1 or on Days 1 and 8, every 3 weeks or twice, until disease progression, intolerability, or death occurs. The Osimertinib Mesylate Tablets treatment regimen is 80 mg, orally, once daily, until disease progression, intolerability, or death.
Expansion cohort 2: two groups participants treated with ALK202 at two different doses in combination with Ivonescimab Injection. Each dose group includes 30 participants, totaling 60 participants, and they are randomly assigned in a 1:1 ratio. The ALK202 treatment regimen involves intravenous infusion, on Day 1 or on Days 1 and 8, every 3 weeks or twice. Until the disease progresses or becomes intolerable or leads to death; the Ivonescimab Injection treatment regimen is 20 mg/kg, administered intravenously, once every 3 weeks, until the disease progresses or becomes intolerable or leads to death.
Expansion cohort 3: participants will select two dosing regimens from the two-drug combination of ALK202+Ivonescimab Injection or the three-drug combination of ALK202 +Ivonescimab Injection+ Carboplatin for exploration based on the preliminary safety and efficacy results of ascending cohort 2 and ascending cohort 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort1 | Experimental | Drug: ALK202 for injection, Combination Product: Osimertinib Mesylate TabletsParticipants with Non-squamous NSCLC with EGFR mutation that has not received systemic palliative treatment, using the ALK202 combine with the Osimertinib Mesylate Tablets treatment |
| cohort2 | Experimental | Drug: ALK202 for injection, Combination Product: Ivonescimab InjectionParticipants with NSCLC (non-small cell lung cancer) who have not received systemic palliative treatment, with PD-L1 expression ≥ 1% and high c-MET expression, and without any driver gene mutations; using the ALK202 combine with the Ivonescimab Injection treatment |
| cohort3 | Experimental | Drug: ALK202 for injection, Combination Product: Ivonescimab Injection, Combination Product: carboplatin injectionParticipants with NSCLC (non-small cell lung cancer) who have not received systemic palliative treatment, with PD-L1 expression < 1% and high c-MET expression, and without any driver gene mutations; using the ALK202 combine with the Ivonescimab Injection and carboplatin injection treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The trial Participants themselves (and/or guardians) have understood and agreed to follow the study procedures and voluntarily signed the ICF;
- Men and women ≥18 and ≤75 years old on the day of signing the ICF;
- The trial participants agree to provide fresh or archived tumor tissues for the detection of the expression status of driving genes or proteins (such as EGFR expression, c-MET expression, and PD-L1 expression status, etc.). If the trial participants are unable to provide the required tumor tissues for testing, their participation in the trial must be approved by the sponsor;
- The presence of at least one measurable lesion is required according to the RECIST v1.1 criteria. A neoplastic lesion that has received local treatment, such as radiotherapy, can be taken as a target lesion if disease progression is proved by imaging;
- Expected survival ≥ 3 months;
Key exclusion criteria (5 listed)
- Previously received EGFR- and/or MET-targeting ADCs and/or ADCs with topoisomerase I inhibitor as the payload;
- Participated in other interventional clinical trials within 4 weeks or 5 drug half-lives before the first dose of ALK202 (whichever is shorter). Note: Patients who have participated in another interventional clinical trial, even if they are still in the survival follow-up period of the previous trial, may be enrolled in this study provided that the first dose of ALK202 is to be administered ≥5 half-lives or 4 weeks from the last dose of the trial drug (whichever is shorter);
- Received chemotherapy, targeted therapy, immunotherapy, interventional procedure, or other systemic antitumor therapy within 4 weeks (Note: 6 weeks for nitrosourea or mitomycin C, 2 weeks or 5 half-lives of the drugs [whichever is shorter] for oral fluorouracil and small-molecule targeted drugs, and 2 weeks for Chinese medicines with anti-tumor indications) prior to the first dose of ALK202;
- Received radical radiotherapy, whole-brain radiotherapy, or bone marrow irradiation > 30% within 4 weeks before the first dose of ALK202; or palliative radiation (including stereotactic radiotherapy) of non-target lesions for symptom relief purposes within 2 weeks prior to the first dose;
- Took drugs or food that strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4 within 2 weeks or within 5 half-lives prior to the first dose of ALK202, whichever is longer.
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 |
|---|---|---|
| ALK202 for injectionThis study employs combined medication. The participants in different groups are treated for non-small cell lung cancer using ALK202 in combination with various drugs. | Drug | cohort1, cohort2, cohort3 |
| Osimertinib Mesylate TabletsCombination Drug 1: Osimertinib Mesylate Tablets, ALK202 combine with Osimertinib Mesylate Tablets for cohort1 enrolled participants | Combination product | cohort1 |
| Ivonescimab InjectionCombination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection for cohort2 enrolled participants | Combination product | cohort2, cohort3 |
| carboplatin injectionCombination product 2: Ivonescimab Injection, ALK202 combine with Ivonescimab Injection and carboplatin injection for cohort3 enrolled participants | Combination product | cohort3 |
Primary outcome
TEAEs
Time frame: Up to 12 months
Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0
6 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Up to 12 months
ADAs
Time frame: Up to 12 months
Area under the plasma concentration versus time curve (AUC)
Time frame: up to 12 months
Objective Response Rate(ORR)
Time frame: Up to 12 months
Disease Control Rate (DCR)
Time frame: Up to 12 months
Progression-FreeSurvival (PFS)
Time frame: Up to 12 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 22 May 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALK202 for injection, Osimertinib Mesylate Tablets and Ivonescimab Injection in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Shanghai Allink Biotherapeutics Co., Ltd..
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 5 inclusion and 5 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mei Tian, Master (+8615800960592, mtian@allinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAEs (time frame: Up to 12 months). 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 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.