SCLC, Extensive StagePhase 2Aurora003NCT07632209
Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment
A Phase 2 study testing Lomustine and Anlotinib in people with SCLC, Extensive Stage, run by Yayi He.
Trial summary
This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Extensive Stage
- What is being tested?
- Lomustine and Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: Aged 18-75 years, without gender restriction.
- 2: Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), classified as extensive-stage disease according to the Veterans Administration Lung Study Group (VALSG) staging system.
- 3: Has received at least two lines of prior systemic antitumor therapy.
- 4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.
- 5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 6: Adequate organ function meeting the following criteria: Hematological function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 100×10⁹/L; hemoglobin (Hb) ≥ 90 g/L. Hepatic and renal function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); serum creatinine (Cr) ≤ 1.5×ULN; estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m². Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- 7: Expected survival time ≥ 3 months.
- 8: Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.
Who cannot join
- 1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.
- 2: Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy).
- 3: Active bleeding or high bleeding risk (e.g., history of massive gastrointestinal hemorrhage or cerebral hemorrhage within the past 6 months, or presence of unhealed wounds or ulcers).
- 4: Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or severe cardiovascular diseases (e.g., myocardial infarction, severe arrhythmia, heart failure within the past 6 months).
- 5: Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases).
- 6: Pregnant or lactating females. Female participants must use effective contraception during treatment and for 6 months after the last dose of study treatment; male participants must use effective contraception during treatment and for 3 months after the last dose of study treatment.
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- 7: History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and other cured malignancies.
- 8: Known hypersensitivity to lomustine, anlotinib, or any excipient in their formulations.
- 9: Any other condition deemed inappropriate for participation in this study by the investigator (e.g., mental disorders, inability to comply with follow-up procedures).
About this study
Official title: A Single-arm, Phase II Interventional Study to Evaluate the Efficacy and Safety of Lomustine Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Further Lines of Treatment
This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.
Read the detailed description
This is a single-arm phase II clinical study evaluating the efficacy and safety of lomustine combined with anlotinib in extensive-stage small cell lung cancer resistant to second-line and subsequent treatments. A total of 46 patients with extensive-stage small cell lung cancer who have received at least two lines of prior systemic therapy will be enrolled and treated with lomustine plus anlotinib. The primary endpoint is investigator-assessed objective response rate (ORR). Secondary endpoints include investigator-assessed progression-free survival (PFS), investigator-assessed disease control rate (DCR), intracranial response rate assessed per RANO criteria (RANO-IRR), investigator-assessed overall survival (OS), adverse events, quality of life (QOL) scores and safety profiles.
- Conditions
- SCLC, Extensive Stage
- Being tested
- Lomustine, Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LomustineDrug
Oral lomustine 60 mg/m² once daily on day 1, every 6 weeks
AnlotinibDrug
Oral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| lomustine combined with anlotinib | Experimental | Oral lomustine 60 mg/m² once daily on day 1 every 6 weeks, combined with oral anlotinib. The initial dose of anlotinib is determined by the investigator, with optional doses of 12 mg, 10 mg or 8 mg once daily on days 1 to 14 every 3 weeks. Receives: Drug: Lomustine; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib
Measured: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
Secondary outcomes (4)
progression free survival
Time from first treatment to disease progression or death from any cause, whichever occurs first
Measured: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
Disease Control Rate (DCR)
According to RECIST 1.1, proportion of subjects achieving CR, PR, or stable disease (SD) in total enrolled population
Measured: Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first，assessed up to approximately 24 months
Adverse Event (AE)
Record all new or worsening unfavorable medical events, grade and calculate incidence according to CTCAE 5.0
Measured: From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months
Quality of Life Score（QOL Score）
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was adopted for patient self-assessment. The scale consists of 30 items, including 5 functional scales, 9 symptom scales and 1 global health status / quality of life scale. Each item is scored on a 1-4 Likert scale, and all scale scores are standardized to a range of 0-100. Higher scores in functional and global quality of life scales and lower scores in symptom scales indicate better quality of life and health status of patients.
Measured: At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- 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
- Model description
- Single-center, single-arm, open-label, non-randomized, exploratory interventional study.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yayi He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yayi He, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632209
- Sponsor's protocol ID
- 2026LY0102
- Other IDs
- MR-31-26-032631
- Acronym
- Aurora003
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Interventional Study to Evaluate the Efficacy and Safety of Lomustine Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Further Lines of Treatment
- ClinicalTrials.gov ID
- NCT07632209
- Acronym / sponsor ID
- Aurora003 / 2026LY0102
- Conditions
- SCLC, Extensive Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Yayi HeUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jun 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.
This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.
Detailed description
This is a single-arm phase II clinical study evaluating the efficacy and safety of lomustine combined with anlotinib in extensive-stage small cell lung cancer resistant to second-line and subsequent treatments. A total of 46 patients with extensive-stage small cell lung cancer who have received at least two lines of prior systemic therapy will be enrolled and treated with lomustine plus anlotinib. The primary endpoint is investigator-assessed objective response rate (ORR). Secondary endpoints include investigator-assessed progression-free survival (PFS), investigator-assessed disease control rate (DCR), intracranial response rate assessed per RANO criteria (RANO-IRR), investigator-assessed overall survival (OS), adverse events, quality of life (QOL) scores and safety profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm, open-label, non-randomized, exploratory interventional study.
| Arm | Type | Receives |
|---|---|---|
| lomustine combined with anlotinib | Experimental | Drug: Lomustine, Drug: AnlotinibOral lomustine 60 mg/m² once daily on day 1 every 6 weeks, combined with oral anlotinib. The initial dose of anlotinib is determined by the investigator, with optional doses of 12 mg, 10 mg or 8 mg once daily on days 1 to 14 every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1: Aged 18-75 years, without gender restriction.
- 2: Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), classified as extensive-stage disease according to the Veterans Administration Lung Study Group (VALSG) staging system.
- 3: Has received at least two lines of prior systemic antitumor therapy.
- 4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.
- 5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (9 listed)
- 1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.
- 2: Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy).
- 3: Active bleeding or high bleeding risk (e.g., history of massive gastrointestinal hemorrhage or cerebral hemorrhage within the past 6 months, or presence of unhealed wounds or ulcers).
- 4: Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or severe cardiovascular diseases (e.g., myocardial infarction, severe arrhythmia, heart failure within the past 6 months).
- 5: Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases).
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 |
|---|---|---|
| LomustineOral lomustine 60 mg/m² once daily on day 1, every 6 weeks | Drug | lomustine combined with anlotinib |
| AnlotinibOral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle | Drug | lomustine combined with anlotinib |
Primary outcome
Objective Response Rate
Time frame: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib
4 secondary outcomes
progression free survival
Time frame: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first，assessed up to approximately 24 months
Adverse Event (AE)
Time frame: From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months
Quality of Life Score（QOL Score）
Time frame: At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 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 8 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lomustine and Anlotinib in people with SCLC, Extensive Stage, run by Yayi He.
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 8 inclusion and 9 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 8 Jun 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?
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?
Objective Response Rate (time frame: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 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 8 Jun 2026.