NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2NCT07742956
Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants.
A Phase 2 study testing ALK201 for injection and Ivonescimab Injection in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Shanghai Allink Biotherapeutics Co., Ltd..
Trial summary
This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- ALK201 for injection and Ivonescimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 31 Dec 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject fully understands and agrees to comply with all study procedures, and voluntarily signs the pre-screening informed consent form and main study informed consent form.
- Aged ≥18 years and ≤75 years at the time of informed consent signature, with no gender restriction.
- Expected overall survival ≥3 months.
- At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with radiotherapy or other local therapies may serve as target lesions if radiological evidence of disease progression in such lesions is confirmed.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Subjects must have adequate organ function, and have not received blood transfusion or hematopoietic growth factor support within 14 days prior to the first administration of ALK201.
- Serum pregnancy test result is negative for female subjects of childbearing potential during the screening period.
Who cannot join
- Adverse events related to prior anti-tumor therapy have not recovered to Grade ≤1 per NCI-CTCAE Version 6.0. Exceptions include alopecia, hypothyroidism stabilized with hormone replacement therapy, and Grade 2 toxicities judged by the Investigator to pose no safety risk (Grade 2 neuropathy is excluded).
- Use of strong cytochrome P450 (CYP) 3A4 inhibitors, strong CYP3A4 inducers, or relevant foods within 2 weeks or 5 half-lives prior to the first administration of ALK201 and combination therapy, whichever is longer.
- History of other malignancies besides the study disease within 5 years prior to enrollment, except malignancies cured by radical treatment without evidence of recurrence, such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, low-risk prostate cancer, and ductal carcinoma in situ of the breast.
- Presence of clinically symptomatic, poorly controlled, or recurrently drained pleural effusion, pericardial effusion, or ascites.
- Planned major surgery during study treatment, or subjects within the postoperative recovery period following major surgery. Subjects with prior major surgery must fully recover from surgical toxicities and/or complications to Grade ≤1 per CTCAE v6.0 before the first study drug administration; otherwise, they will be excluded.
- Evidence of severe or uncontrolled systemic diseases (e.g., decompensated respiratory, hepatic, or renal disorders).
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- History of solid organ transplantation or hematopoietic stem cell transplantation.
- Administration of live attenuated vaccines within 4 weeks before the first dose of ALK201.
- Female subjects who are pregnant or breastfeeding.
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-label, Multicenter Phase II Clinical Trial to Evaluate ALK201 for Injection Combined With Ivonescimab Injection in Subjects With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are FGFR2b-positive, EGFR mutation-negative, and ALK-negative. The study consists of two parts: Part A (dose escalation) and Part B (dose optimization).
Part A Dose Escalation Stage: This stage includes three dose levels. Eligible patients with locally advanced or metastatic sqNSCLC who have failed standard therapy will be enrolled to complete DLT assessment.
Read more
Part B Dose Optimization Stage: This stage comprises two cohorts, enrolling eligible patients with locally advanced or metastatic sqNSCLC satisfying the respective cohort criteria:
Primary cohort: PD-L1 expression ≥1% Exploratory cohort: PD-L1 expression <1%
Read the detailed description
This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are FGFR2b-positive, EGFR mutation-negative, and ALK-negative. The study consists of two parts: Part A (dose escalation) and Part B (dose optimization).
Part A Dose Escalation Stage: This stage includes three dose levels. Eligible patients with locally advanced or metastatic sqNSCLC who have failed standard therapy will be enrolled to complete DLT assessment.
Part B Dose Optimization Stage: This stage comprises two cohorts, enrolling eligible patients with locally advanced or metastatic sqNSCLC satisfying the respective cohort criteria:
Primary cohort: PD-L1 expression ≥1% Exploratory cohort : PD-L1 expression <1%
- Being tested
- ALK201 for injection, Ivonescimab Injection
- Keywords
- NSCLC, sqNSCLC
- 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.
ALK201 for injectionDrug
Subjects will be randomized 1:1 to the two dose levels selected from Part A. The administered dose will be calculated based on the assigned dose arm and the subject's body weight.
Ivonescimab InjectionDrug
The administered dose will be calculated based on a fixed dose of 20 mg/kg and the subject's body weight.
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | Experimental | Patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) with PD-L1 expression ≥1% will be treated with ALK201 for Injection combined with Ivonescimab Injection, or Ivonescimab Injection monotherapy. Two doses of ALK201 selected from Part A will be applied in the combination arms, with subjects randomized 1:1 between the two ALK201 combination dose groups. Receives: Drug: ALK201 for injection; Drug: Ivonescimab Injection |
| Exploratory cohort | Experimental | Subjects with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) and PD-L1 expression <1% will receive ALK201 for Injection in combination with Ivonescimab Injection. Two recommended doses of ALK201 identified in Part A will be used, and subjects will be randomized 1:1 between the two combination dose arms. Receives: Drug: ALK201 for injection; Drug: Ivonescimab 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 24 months
Secondary outcomes (6)
Peak Plasma Concentration (Cmax)
PK parameters after single andmultiple doses
Measured: Up to 24 months
ADAs
The generation of anti-drug antibodies
Measured: Up to 24 months
Area under the plasma concentration versus time curve (AUC)
PK parameters after single andmultiple doses
Measured: up to 24 months
Objective Response Rate(ORR)
Objective Response Rate(ORR) calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria
Measured: Up to 24 months
Disease Control Rate (DCR)
DCR calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria
Measured: Up to 24 months
Progression-FreeSurvival (PFS)
PFS calculated based onthe Response Evaluation Criteria InSolid Tumors (RECIST) v1.1 criteria
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (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
- 156 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
- NCT07742956
- Sponsor's protocol ID
- ALK201-03
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase II Clinical Trial to Evaluate ALK201 for Injection Combined With Ivonescimab Injection in Subjects With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07742956
- Acronym / sponsor ID
- ALK201-03
- Keywords
- NSCLC, sqNSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Aug 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 is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are FGFR2b-positive, EGFR mutation-negative, and ALK-negative. The study consists of two parts: Part A (dose escalation) and Part B (dose optimization).
Part A Dose Escalation Stage: This stage includes three dose levels. Eligible patients with locally advanced or metastatic sqNSCLC who have failed standard therapy will be enrolled to complete DLT assessment.
Part B Dose Optimization Stage: This stage comprises two cohorts, enrolling eligible patients with locally advanced or metastatic sqNSCLC satisfying the respective cohort criteria:
Primary cohort: PD-L1 expression ≥1% Exploratory cohort: PD-L1 expression <1%
Detailed description
This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are FGFR2b-positive, EGFR mutation-negative, and ALK-negative. The study consists of two parts: Part A (dose escalation) and Part B (dose optimization).
Part A Dose Escalation Stage: This stage includes three dose levels. Eligible patients with locally advanced or metastatic sqNSCLC who have failed standard therapy will be enrolled to complete DLT assessment.
Part B Dose Optimization Stage: This stage comprises two cohorts, enrolling eligible patients with locally advanced or metastatic sqNSCLC satisfying the respective cohort criteria:
Primary cohort: PD-L1 expression ≥1% Exploratory cohort : PD-L1 expression <1%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | Experimental | Drug: ALK201 for injection, Drug: Ivonescimab InjectionPatients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) with PD-L1 expression ≥1% will be treated with ALK201 for Injection combined with Ivonescimab Injection, or Ivonescimab Injection monotherapy. Two doses of ALK201 selected from Part A will be applied in the combination arms, with subjects randomized 1:1 between the two ALK201 combination dose groups. |
| Exploratory cohort | Experimental | Drug: ALK201 for injection, Drug: Ivonescimab InjectionSubjects with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) and PD-L1 expression <1% will receive ALK201 for Injection in combination with Ivonescimab Injection. Two recommended doses of ALK201 identified in Part A will be used, and subjects will be randomized 1:1 between the two combination dose arms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject fully understands and agrees to comply with all study procedures, and voluntarily signs the pre-screening informed consent form and main study informed consent form.
- Aged ≥18 years and ≤75 years at the time of informed consent signature, with no gender restriction.
- Expected overall survival ≥3 months.
- At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with radiotherapy or other local therapies may serve as target lesions if radiological evidence of disease progression in such lesions is confirmed.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
Key exclusion criteria (9 listed)
- Adverse events related to prior anti-tumor therapy have not recovered to Grade ≤1 per NCI-CTCAE Version 6.0. Exceptions include alopecia, hypothyroidism stabilized with hormone replacement therapy, and Grade 2 toxicities judged by the Investigator to pose no safety risk (Grade 2 neuropathy is excluded).
- Use of strong cytochrome P450 (CYP) 3A4 inhibitors, strong CYP3A4 inducers, or relevant foods within 2 weeks or 5 half-lives prior to the first administration of ALK201 and combination therapy, whichever is longer.
- History of other malignancies besides the study disease within 5 years prior to enrollment, except malignancies cured by radical treatment without evidence of recurrence, such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, low-risk prostate cancer, and ductal carcinoma in situ of the breast.
- Presence of clinically symptomatic, poorly controlled, or recurrently drained pleural effusion, pericardial effusion, or ascites.
- Planned major surgery during study treatment, or subjects within the postoperative recovery period following major surgery. Subjects with prior major surgery must fully recover from surgical toxicities and/or complications to Grade ≤1 per CTCAE v6.0 before the first study drug administration; otherwise, they will be excluded.
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 |
|---|---|---|
| ALK201 for injectionSubjects will be randomized 1:1 to the two dose levels selected from Part A. The administered dose will be calculated based on the assigned dose arm and the subject's body weight. | Drug | Exploratory cohort, Primary cohort |
| Ivonescimab InjectionThe administered dose will be calculated based on a fixed dose of 20 mg/kg and the subject's body weight. | Drug | Exploratory cohort, Primary cohort |
Primary outcome
TEAEs
Time frame: Up to 24 months
Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0
6 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Up to 24 months
ADAs
Time frame: Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Time frame: up to 24 months
Objective Response Rate(ORR)
Time frame: Up to 24 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Progression-FreeSurvival (PFS)
Time frame: Up to 24 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 Aug 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 ALK201 for injection 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 7 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 3 Aug 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 Chaochao Du (+8613122503303, ccdu@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 24 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 3 Aug 2026.