Squamous Non-Small Cell Lung Cancer (NSCLC)Phase 2STELLAR-202NCT07845786
Zanzalintinib and Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Carboplatin, Paclitaxel and Nab-paclitaxel in people with Squamous Non-Small Cell Lung Cancer (NSCLC), run by Exelixis.
Trial summary
The primary purpose of the study is to evaluate the effectiveness of zanzalintinib in combination with pembrolizumab as first-line maintenance therapy in participants with metastatic squamous NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Carboplatin, Paclitaxel and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 15 Jun 2030
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 6 months.
- Stage IV squamous NSCLC as defined by American Joint Committee on Cancer (AJCC) 9th Edition.
- Measurable disease according to RECIST v1.1 as determined by the investigator and documented prior to starting induction therapy.
- Programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) < 50% as assessed per local testing. To minimize assay variability, local laboratory must ascertain PD-L1 status using the PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx assay.
Who cannot join
- Nonsquamous histology NSCLC.
- Tumor invasion, encasement of organs, or major blood vessels, if poses a significant increased risk of bleeding.
- Targetable genomic aberrations for which approved targeted therapy is available.
- The participant has uncontrolled, significant intercurrent or recent illness.
- Active autoimmune disease or a history of autoimmune disease within 2 years prior to the first dose of induction therapy requiring systemic immunosuppressive therapy.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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: A Phase 2, Single-Arm, Multicenter Trial of Zanzalintinib in Combination With Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer
The primary purpose of the study is to evaluate the effectiveness of zanzalintinib in combination with pembrolizumab as first-line maintenance therapy in participants with metastatic squamous NSCLC.
- Being tested
- Carboplatin, Paclitaxel, Nab-paclitaxel, Pembrolizumab, Zanzalintinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Administered as part of SOC therapy as specified in the treatment arm.
PaclitaxelDrug
Administered as part of SOC therapy as specified in the treatment arm.
Nab-paclitaxelDrug
Administered as part of SOC therapy as specified in the treatment arm.
PembrolizumabDrug
Administered as specified in the treatment arm.
ZanzalintinibDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Zanzalintinib + Pembrolizumab | Experimental | Participants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician.
Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pembrolizumab; Drug: Zanzalintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) at 6 Months (PFS-6) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator
Measured: 6 months
Secondary outcomes (5)
Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
Measured: Up to 30 months
Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator
Measured: Up to 30 months
PFS per RECIST v1.1 as assessed by Investigator
Measured: Up to 30 months
Overall Survival (OS)
Measured: Up to 30 months
Number of Participants With Adverse Events (AEs)
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845786
- Sponsor's protocol ID
- XL092-202
- Acronym
- STELLAR-202
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm, Multicenter Trial of Zanzalintinib in Combination With Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07845786
- Acronym / sponsor ID
- STELLAR-202 / XL092-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 29 Sep 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.
The primary purpose of the study is to evaluate the effectiveness of zanzalintinib in combination with pembrolizumab as first-line maintenance therapy in participants with metastatic squamous NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanzalintinib + Pembrolizumab | Experimental | Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab-paclitaxel, Drug: Pembrolizumab, Drug: ZanzalintinibParticipants will receive 4 cycles of once every 3 weeks (Q3W) induction therapy with pembrolizumab and standard of care (SOC) as prescribed by their treating physician. Participants with complete response (CR), partial response (PR), or stable disease (SD) after induction therapy will begin treatment with zanzalintinib and pembrolizumab (maintenance therapy) via intravenous (IV) infusion Q3W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 6 months.
- Stage IV squamous NSCLC as defined by American Joint Committee on Cancer (AJCC) 9th Edition.
- Measurable disease according to RECIST v1.1 as determined by the investigator and documented prior to starting induction therapy.
- Programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) < 50% as assessed per local testing. To minimize assay variability, local laboratory must ascertain PD-L1 status using the PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx assay.
Key exclusion criteria (6 listed)
- Nonsquamous histology NSCLC.
- Tumor invasion, encasement of organs, or major blood vessels, if poses a significant increased risk of bleeding.
- Targetable genomic aberrations for which approved targeted therapy is available.
- The participant has uncontrolled, significant intercurrent or recent illness.
- Active autoimmune disease or a history of autoimmune disease within 2 years prior to the first dose of induction therapy requiring systemic immunosuppressive 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 |
|---|---|---|
| CarboplatinAdministered as part of SOC therapy as specified in the treatment arm. | Drug | Zanzalintinib + Pembrolizumab |
| PaclitaxelAdministered as part of SOC therapy as specified in the treatment arm. | Drug | Zanzalintinib + Pembrolizumab |
| Nab-paclitaxelAdministered as part of SOC therapy as specified in the treatment arm. | Drug | Zanzalintinib + Pembrolizumab |
| PembrolizumabAdministered as specified in the treatment arm. | Drug | Zanzalintinib + Pembrolizumab |
| ZanzalintinibAdministered as specified in the treatment arm. | Drug | Zanzalintinib + Pembrolizumab |
Primary outcome
Progression-Free Survival (PFS) at 6 Months (PFS-6) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator
Time frame: 6 months
5 secondary outcomes
Objective Response Rate (ORR) per RECIST v1.1 as assessed by Investigator
Time frame: Up to 30 months
Duration of Response (DOR) per RECIST v1.1 as assessed by Investigator
Time frame: Up to 30 months
PFS per RECIST v1.1 as assessed by Investigator
Time frame: Up to 30 months
Overall Survival (OS)
Time frame: Up to 30 months
Number of Participants With Adverse Events (AEs)
Time frame: Up to 30 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 29 Sep 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.
Medical Director study director
Exelixis
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Paclitaxel and Nab-paclitaxel in people with Squamous Non-Small Cell Lung Cancer (NSCLC), run by Exelixis.
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 6 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 29 Sep 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 Exelixis Clinical Trials (1-888-393-5494, druginfo@exelixis.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) at 6 Months (PFS-6) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator (time frame: 6 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 29 Sep 2026.