Extensive-stage Small Cell Lung CancerPhase 2NCT04373369
Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Vorolanib and Atezolizumab in people with Extensive-stage Small Cell Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to determine whether adding vorolanib to atezolizumab will improve the length of time that participants are cancer-free after receiving standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Vorolanib and Atezolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2020to 11 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically confirmed extensive stage small cell lung cancer without prior specific systemic therapy aside from induction with platinum, etoposide, and atezolizumab. Measurable disease is not required for eligibility.
- Receipt of at least 3 cycles (and no more than 4 cycles) of platinum plus etoposide and atezolizumab during the induction phase, without tumor progression as determined by CT scan and brain MRI. Patients should be able to start the study treatment no more than 6 weeks from the last dose of induction chemo/immunotherapy. This period may be extended to 8 weeks in patients requiring brain radiotherapy after completion of induction chemo/immunotherapy for brain metastases.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.5 K/cumm
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- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases)
- Creatinine ≤ 1.5 x IULN OR measured or calculated creatinine clearance > 50 mL/min for patients with creatinine levels > 1.5 x IULN
- Urine protein ≤ 1+ or urine protein to creatinine ratio ≤ 1; if UPC ratio is > 1 on urinalysis, then 24-hour urine collection for protein must be obtained and level must be < 1,000 mg for patient enrollment
- aPTT and either INR or PT ≤ 1.5 x IULN unless participant is receiving anticoagulant therapy as long as PT or a PTT is within therapeutic range of intended use of anticoagulants.
- Patients receiving therapeutic non-Coumadin anticoagulation are eligible, provided they are on a stable dose (per investigator judgment) of anticoagulant.
- The effects of atezolizumab and vorolanib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 31 weeks after last dose of study treatment. Women must use birth control for at least 31 weeks after last dose of study treatment. Women must not be breastfeeding.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Currently receiving any other investigational agents.
- Patients with untreated brain metastases are excluded. Patients with clinically evident CNS hemorrhage are excluded. Prophylactic cranial irradiation is not allowed. Patients with brain metastases treated with whole brain radiation therapy, radiosurgery, or surgery are eligible.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorolanib, atezolizumab, or other agents used in the study.
- Use of chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
- Systemic glucocorticoids with prednisone dose higher than 10 mg/day or equivalent.
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- Arterial or venous thromboembolic event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment.
- Uncontrolled or poorly controlled hypertension with systolic blood pressure (BP)> 160 mmHg systolic or diastolic > 100 mmHg for > 3 weeks prior to C1D1), despite standard medical management.
- Gastrointestinal perforation, and/or fistula, or risk factors for perforation within 6 months prior to enrollment.
- Grade 3 or 4 gastrointestinal bleeding within 3 months prior to enrollment.
- History of active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan.
- Hemoptysis (defined as bright red blood or ≥ ½ teaspoon) within 28 days prior to Cycle 1 Day 1 or with radiographic evidence of intratumor cavitation or radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to Cycle 1 Day 1.
- Undergone major surgery within 28 days prior to Cycle 1 Day 1, or minor surgery/subcutaneous venous access device placement within 7 days prior to Cycle 1 Day 1, or has elective or planned major surgery to be performed during the course of the clinical trial.
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis at a level of Child-Pugh B or worse, cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (defined as ascites from cirrhosis requiring diuretics or paracentesis), fatty liver, and inherited liver disease.
- Active tuberculosis.
- Administration of a live, attenuated influenza vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study.
- Severe infections within 2 weeks prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Received oral or intravenous (IV) antibiotics within 2 weeks prior to Cycle 1 Day 1. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
- History of deep venous thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to Cycle 1 Day 1.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to C1D1.
- Active hepatitis B (chronic or acute) defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Note: Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test are eligible.
- Patients known to be HIV positive are ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase II Study of Maintenance Vorolanib and Atezolizumab in Patients With Extensive-stage SCLC
The purpose of the study is to determine whether adding vorolanib to atezolizumab will improve the length of time that participants are cancer-free after receiving standard chemotherapy.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Vorolanib, Atezolizumab
- Keywords
- Extensive stage small cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorolanibDrug
Also called X-82
Vorolanib is administered orally at a dose of 200 mg on Days 1 through 21 of each 21-day cycle.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Vorolanib + Atezolizumab | Experimental | Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily. Receives: Drug: Vorolanib; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months
- Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
- Kaplan-Meier product limit estimator will be used to estimate progression-free survival (PFS) at 6 months, with the inclusion of 90% confidence interval.
Measured: 6 months
Secondary outcomes (3)
Median Progression-free Survival (PFS)
- Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Measured: Through completion of follow-up for progression-free survival (median length of follow-up 81 days, full range 25-1526 days)
Median Overall Survival
Overall survival is defined as the length of time from the start of study treatment that patients diagnosed with the disease are still alive.
Measured: Through completion of follow-up (median length of follow-up 446 days, full range 93-1526 days)
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Measured: From the start of treatment until 90 days after completion of treatment (median length of follow-up 165 days, full range 93-527 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start7 Oct 2020
- Primary completion18 Aug 2022
- Study completion11 Aug 2025
Why it stopped: Insufficient Funding/Staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xcovery Holdings, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel Morgensztern, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373369
- Sponsor's protocol ID
- 202007036
- Status last verified
- Oct 2025
- First submitted
- 30 Apr 2020
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Maintenance Vorolanib and Atezolizumab in Patients With Extensive-stage SCLC
- ClinicalTrials.gov ID
- NCT04373369
- Acronym / sponsor ID
- 202007036
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- Extensive stage small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Funding/Staff
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Xcovery Holdings, Inc.
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Posted 2 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether adding vorolanib to atezolizumab will improve the length of time that participants are cancer-free after receiving standard chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorolanib + Atezolizumab | Experimental | Drug: Vorolanib, Drug: AtezolizumabConsenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed extensive stage small cell lung cancer without prior specific systemic therapy aside from induction with platinum, etoposide, and atezolizumab. Measurable disease is not required for eligibility.
- Receipt of at least 3 cycles (and no more than 4 cycles) of platinum plus etoposide and atezolizumab during the induction phase, without tumor progression as determined by CT scan and brain MRI. Patients should be able to start the study treatment no more than 6 weeks from the last dose of induction chemo/immunotherapy. This period may be extended to 8 weeks in patients requiring brain radiotherapy after completion of induction chemo/immunotherapy for brain metastases.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Normal bone marrow and organ function as defined below:
Key exclusion criteria (24 listed)
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Currently receiving any other investigational agents.
- Patients with untreated brain metastases are excluded. Patients with clinically evident CNS hemorrhage are excluded. Prophylactic cranial irradiation is not allowed. Patients with brain metastases treated with whole brain radiation therapy, radiosurgery, or surgery are eligible.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorolanib, atezolizumab, or other agents used in the study.
- Use of chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
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 |
|---|---|---|
| VorolanibAlso: X-82Vorolanib is administered orally at a dose of 200 mg on Days 1 through 21 of each 21-day cycle. | Drug | Vorolanib + Atezolizumab |
| AtezolizumabAlso: TecentriqAtezolizumab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle. | Drug | Vorolanib + Atezolizumab |
Primary outcome
Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months
Time frame: 6 months
* Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) * Kaplan-Meier product limit estimator will be used to estimate progression-free survival (PFS) at 6 months, with the inclusion of 90% confidence interval.
3 secondary outcomes
Median Progression-free Survival (PFS)
Time frame: Through completion of follow-up for progression-free survival (median length of follow-up 81 days, full range 25-1526 days)
Median Overall Survival
Time frame: Through completion of follow-up (median length of follow-up 446 days, full range 93-1526 days)
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events
Time frame: From the start of treatment until 90 days after completion of treatment (median length of follow-up 165 days, full range 93-527 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Daniel Morgensztern, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vorolanib and Atezolizumab in people with Extensive-stage Small Cell Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
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 16 inclusion and 24 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: stopped early, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 2 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months (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 3 Nov 2025.