Small Cell Lung Cancer Extensive StageNCT06982287
A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy Maintenance Therapy Following Standard Chemoimmunotherapy for ES-SCLC (ALTER-L059)
An observational study of Small Cell Lung Cancer Extensive Stage, run by Yong Fang.
Trial summary
This retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with treatment-naïve extensive-stage small cell lung cancer (ES-SCLC) who achieved non-progression after chemoimmunotherapy induction and received anlotinib plus immunotherapy maintenance therapy
Who may be able to join
- Male or female patients aged 18 years or older;
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (per the Veterans Administration Lung Study Group [VALG] staging criteria);
- Patients who previously received chemotherapy for limited-stage SCLC must have undergone curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) and have a treatment-free interval of at least 6 months from the end of prior therapy (last chemotherapy cycle or radiotherapy) to the diagnosis of ES-SCLC;
- At least one measurable target lesion (per RECIST version 1.1 criteria);
- No disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for ES-SCLC;
- ECOG performance status: 0-2;
- Life expectancy ≥3 months.
Who cannot join
- Patients with limited-stage SCLC who previously received chemotherapy and underwent curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) but experienced disease recurrence within 6 months after completion of prior therapy;
- Patients with limited-stage SCLC who previously received immunotherapy agents (e.g., PD-1/PD-L1 inhibitors) or anti-angiogenic agents (e.g., Anlotinib, Apatinib, Bevacizumab);
- Patients with extensive-stage small cell lung cancer (ES-SCLC) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen;
- Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose;
- Patients with coagulation dysfunction, defined as an International Normalized Ratio (INR) >1.5 or activated partial thromboplastin time (APTT) >1.5 × upper limit of normal (ULN), and/or those with a bleeding tendency;
- Patients deemed by the inves.
About this study
Official title: A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy as Maintenance Therapy Following First-Line Chemoimmunotherapy in Treatment-Naïve Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ALTER-L059)
This retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. The primary objectives are progression-free survival (PFS)，overall survival (OS)
, and safety.
Read the detailed description
This multicenter study seeks to retrospectively analyze medical records (January 2022-December 2024) of extensive-stage small cell lung cancer (ES-SCLC) patients treated with anlotinib hydrochloride (12/10/8 mg doses) alongside immune maintenance therapy after first-line chemoimmunotherapy in real-world clinical settings. Key data points will encompass demographics, baseline disease characteristics, treatment regimens, efficacy outcomes (e.g., objective response rate, progression-free survival), and adverse event profiles. Eligible patients must have received anlotinib for ≥6 weeks and possess evaluable radiographic assessments. The primary objectives are to assess the clinical effectiveness and safety of this combination strategy in ES-SCLC.
- Conditions
- Small Cell Lung Cancer Extensive Stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | patients treated with anlotinib Hydrochloride combined with immunotherapy maintenance therapy following standard chemoimmunotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS2
Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment.
Measured: up to 12 months
Secondary outcomes (7)
PFS
Progress free survival
Measured: up to 12 months
6-month PFS rate
Progress free survival rate at 6 months after diagnosis.
Measured: up to 12 months
12-month PFS rate
Progress free survival rate at 12 months after diagnosis.
Measured: up to 12 months
OS
Overall Survival
Measured: From diagnosis until death (up to 24 months)
6-month OS rate
Overall survival rate at 6 months after diagnosis.
Measured: up to 12 months
12-month OS rate
Overall survival rate at 12 months after diagnosis.
Measured: up to 24 months
Incidence of Treatment-Emergent Adverse Events
Record Adverse Events (AEs) according to CTCAE (V5.0). Record and analyze the number of abnormal data.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong Fang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Fang, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982287
- Sponsor's protocol ID
- ALTER-L059
- Status last verified
- Jul 2025
- First submitted
- 6 May 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy as Maintenance Therapy Following First-Line Chemoimmunotherapy in Treatment-Naïve Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ALTER-L059)
- ClinicalTrials.gov ID
- NCT06982287
- Acronym / sponsor ID
- ALTER-L059
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yong FangUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 May 2025 (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 retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. The primary objectives are progression-free survival (PFS)，overall survival (OS)
, and safety.
Detailed description
This multicenter study seeks to retrospectively analyze medical records (January 2022-December 2024) of extensive-stage small cell lung cancer (ES-SCLC) patients treated with anlotinib hydrochloride (12/10/8 mg doses) alongside immune maintenance therapy after first-line chemoimmunotherapy in real-world clinical settings. Key data points will encompass demographics, baseline disease characteristics, treatment regimens, efficacy outcomes (e.g., objective response rate, progression-free survival), and adverse event profiles. Eligible patients must have received anlotinib for ≥6 weeks and possess evaluable radiographic assessments. The primary objectives are to assess the clinical effectiveness and safety of this combination strategy in ES-SCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –patients treated with anlotinib Hydrochloride combined with immunotherapy maintenance therapy following standard chemoimmunotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with treatment-naïve extensive-stage small cell lung cancer (ES-SCLC) who achieved non-progression after chemoimmunotherapy induction and received anlotinib plus immunotherapy maintenance therapy
Key inclusion criteria (7 listed)
- Male or female patients aged 18 years or older;
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (per the Veterans Administration Lung Study Group [VALG] staging criteria);
- Patients who previously received chemotherapy for limited-stage SCLC must have undergone curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) and have a treatment-free interval of at least 6 months from the end of prior therapy (last chemotherapy cycle or radiotherapy) to the diagnosis of ES-SCLC;
- At least one measurable target lesion (per RECIST version 1.1 criteria);
- No disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for ES-SCLC;
Key exclusion criteria (6 listed)
- Patients with limited-stage SCLC who previously received chemotherapy and underwent curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) but experienced disease recurrence within 6 months after completion of prior therapy;
- Patients with limited-stage SCLC who previously received immunotherapy agents (e.g., PD-1/PD-L1 inhibitors) or anti-angiogenic agents (e.g., Anlotinib, Apatinib, Bevacizumab);
- Patients with extensive-stage small cell lung cancer (ES-SCLC) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen;
- Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose;
- Patients with coagulation dysfunction, defined as an International Normalized Ratio (INR) >1.5 or activated partial thromboplastin time (APTT) >1.5 × upper limit of normal (ULN), and/or those with a bleeding tendency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS2
Time frame: up to 12 months
Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment.
7 secondary outcomes
PFS
Time frame: up to 12 months
6-month PFS rate
Time frame: up to 12 months
12-month PFS rate
Time frame: up to 12 months
OS
Time frame: From diagnosis until death (up to 24 months)
6-month OS rate
Time frame: up to 12 months
12-month OS rate
Time frame: up to 24 months
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 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 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer Extensive Stage, run by Yong Fang.
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 7 inclusion and 6 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 Jul 2025. 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.
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?
PFS2 (time frame: up to 12 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 Jul 2025.