Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

NCT04373369 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 202007036
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive-stage Small Cell Lung Cancer

Keywords

Extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Median Progression-free Survival (PFS)

  Through completion of follow-up for progression-free survival (median length of follow-up 81 days, full range 25-1526 days)

• Median Overall Survival

  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

  From the start of treatment until 90 days after completion of treatment (median length of follow-up 165 days, full range 93-527 days).

Study Arms (1)

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.

Drug: Vorolanib; Drug: Atezolizumab

Interventions

Vorolanib DRUG

Vorolanib is administered orally at a dose of 200 mg on Days 1 through 21 of each 21-day cycle.

Also known as: X-82

Vorolanib + Atezolizumab

Atezolizumab DRUG

Atezolizumab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.

Also known as: Tecentriq

Vorolanib + Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Xcovery Holdings, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

vorolanib; atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Daniel Morgensztern, M.D.
• Organization: Washington University School of Medicine

danielmorgensztern@wustl.edu

314-362-5817

Study Officials

• Daniel Morgensztern, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: October 7, 2020
• Primary Completion: August 18, 2022
• Study Completion: August 11, 2025
• Last Updated: November 3, 2025
• Results First Posted: June 2, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)