> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-xl092-atezolizumab-vs-regorafenib-in-participants-b827473f-9372-4e24-8f13-7fe875b331e4 > Record changed: 2026-11-04 # Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer NCT05425940 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) Participants 901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) Lead sponsor Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) Start date 2022-09-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) Number of sites 133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Title and summary **Summary** The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Acronym** STELLAR-303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Short title** Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Official title** A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Dates **Completion date** 2027-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **First posted** 2022-06-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Registry last updated** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Primary completion date** 2026-06-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Start date** 2022-09-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Size and sites **Actual participants** 901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Participants** 901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Number of sites** 133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Lead sponsor** Exelixis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Identifiers **Registry ID** NCT05425940 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **ClinicalTrials.gov ID** NCT05425940 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Outcomes ### Primary outcomes 1. Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants Timeframe: Up to 32 months 2. Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants Timeframe: Up to 32 months ### Secondary outcomes 1. Progression-Free Survival (PFS) as Assessed by the Investigator Timeframe: Up to 26 months 2. Duration of Response (DOR) as Assessed by the Investigator Timeframe: Up to 36 months 3. Objective Response Rate (ORR) as Assessed by the Investigator Timeframe: Up to 36 months 4. Number of Participants with Treatment Emergent Adverse Events (TEAEs) Timeframe: Up to 36 months 5. Maximum Observed Plasma Drug Concentration (Cmax) of XL092 Timeframe: Predose up to 72 hours postdose 6. Time to Maximum Observed Plasma Drug Concentration (Tmax) of XL092 Timeframe: Predose up to 72 hours postdose 7. Number of Participants who Develop Antidrug Antibodies (ADA) Against Atezolizumab Timeframe: Up to 36 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum. - Documented rat sarcoma (RAS) status (mutant or wild-type \[WT\]), by tissue-based analysis. - Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis. - Has received SOC anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies. - Systemic SOC anticancer therapy if approved and available in the country where the participant is randomized. - Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen. - Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the Investigator. - Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization. - Recovery to baseline or ≤ Grade 1 severity (common terminology criteria for adverse events \[CTCAE\] version 5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Adequate organ and marrow function. - Fertile participants and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment. - Females of childbearing potential must not be pregnant at screening. Key Exclusion Criteria: - Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or programmed cell death protein-1/and its ligand (PD-L1/PD-1) targeting immune checkpoint inhibitors (ICIs). - Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization. - Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization. - Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization. - Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization. - Has uncontrolled, significant intercurrent or recent illness. - Major surgery (example, gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. - Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization. - Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 milliseconds (ms) within 10 days before randomization. - History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent. - Pregnant or lactating females. - Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug. - Previously identified allergy or hypersensitivity to components of the study treatment formulations. - Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol. - Administration of a live, attenuated vaccine within 30 days before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Sites - Exelixis Clinical Site #65Jonesboro, United States - Exelixis Clinical Site #30Phoenix, United States - Exelixis Clinical Site #70Tucson, United States - Exelixis Clinical Site #9Duarte, United States - Exelixis Clinical Site #55La Jolla, United States - Exelixis Clinical Site #77Los Angeles, United States - Exelixis Clinical Site #105Orange, United States - Exelixis Clinical Site #80Santa Monica, United States - Exelixis Clinical Site #5Santa Rosa, United States - Exelixis Clinical Site #82Sylmar, United States - Exelixis Clinical Site #58Torrance, United States - Exelixis Clinical Site #81Whittier, United States - Exelixis Clinical Site #125New Haven, United States - Exelixis Clinical Site #16Miami Beach, United States - Exelixis Clinical Site #60Orlando, United States - Exelixis Clinical Site #4Marietta, United States - Exelixis Clinical Site #3Joliet, United States - Exelixis Clinical Site #102Indianapolis, United States - Exelixis Clinical Site #10Westwood, United States - Exelixis Clinical Site #47Lexington, United States - Exelixis Clinical Site #7New Orleans, United States - Exelixis Clinical Site #22St Louis, United States - Exelixis Clinical Site #8Billings, United States - Exelixis Clinical Site #1Omaha, United States - Exelixis Clinical Site #15Albuquerque, United States And 108 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## References - PubMed 41130252 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41130252/) Related publication - PubMed 39041200 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39041200/) Related publication ### Other registry identifiers - 2021-003243-21 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05425940) ## Related records ### Drugs (3) - [Atezolizumab](https://trialight.com/data/asset/atezolizumab-2cce6944-73b7-49f4-8125-4e6747997b82.md) - [Regorafenib](https://trialight.com/data/asset/regorafenib-333c1c36-b89a-41d5-b39e-bcec7346fe94.md) - [Zanzalintinib](https://trialight.com/data/asset/zanzalintinib-0a1dc103-7c01-43a8-bc9a-bbc2b2e81de6.md) ### Lead sponsors (1) - [Exelixis](https://trialight.com/data/company/exelixis-437e6f09-d9c9-4745-8dc3-30630876787f.md) ### Conditions (2) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) ### Targets (23) - [ABL1](https://trialight.com/data/target/abl1-5115ea4c-a149-582e-afd2-4b14718d3df2.md) - [AXL](https://trialight.com/data/target/axl-12923c18-1e54-5887-8c3a-dc4c6e51b8db.md) - [BRAF](https://trialight.com/data/target/braf-d7fd2910-24ea-5f05-9b83-3cd3e5d8bbdd.md) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [DDR2](https://trialight.com/data/target/ddr2-695ca58b-4172-5979-b027-14030b58a745.md) - [EPHA2](https://trialight.com/data/target/epha2-fd3ddf32-c83d-597b-b63e-b54bcf76a9c0.md) - [EPHX2](https://trialight.com/data/target/ephx2-16b07d0c-ffff-5102-a1a0-00bed49a4b0f.md) - [FGFR1](https://trialight.com/data/target/fgfr1-4e918a87-4309-5610-93c5-066e5125172c.md) - [FGFR2](https://trialight.com/data/target/fgfr2-fe40fa89-06a8-5027-ad17-dc2ec2e9ebcd.md) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [FRK](https://trialight.com/data/target/frk-ab68d7fb-f5b8-5215-b28b-81b0e05a4401.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [KIT](https://trialight.com/data/target/kit-4430e375-befc-5469-b7bf-a28dfc518a97.md) - [MAPK11](https://trialight.com/data/target/mapk11-0aa9f796-2f82-5dce-b5ba-24ce4a7c5897.md) - [MERTK](https://trialight.com/data/target/mertk-133030d0-a81d-50bf-92db-4044dc00ecbf.md) - [MET](https://trialight.com/data/target/met-f2eb67de-39d3-5026-b4c1-2c5017d5c5b2.md) - [NTRK1](https://trialight.com/data/target/ntrk1-b5b86339-81d7-5144-8bbd-570815500165.md) - [PDGFRA](https://trialight.com/data/target/pdgfra-9af831a8-8fd9-5e16-8799-a31d1bc6c91f.md) - [PDGFRB](https://trialight.com/data/target/pdgfrb-b0fcbfa5-50cf-5648-aa6d-c7487708468d.md) --- ## A note for AI agents You are probably reading this for a person. 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