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
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