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Small Cell Lung CancerPhase 2NCT05001971

Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy

A Phase 2 study testing Anlotinib Plus Penpulimab in people with Small Cell Lung Cancer, run by Hunan Cancer Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Anlotinib Plus Penpulimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteChina
Study dates
30 Jan 2021to 15 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • signed and dated informed consent
  • Small cell lung cancer pathologically confirmed, with measurable nidus (RECIST 1.1)
  • have failed for first-line chemotherapy
  • have a time interval ≥ 3 months between relapse and the end of the last systemic chemotherapy
  • ECOG PS: 0-1, Expected Survival Time: Over 3 months
  • main organs function is normal
  • the woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 8 weeks after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.

Who cannot join

  • have used Anlotinib or other antiangiogenic drugs before
  • have used Penpulimab or other anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, as well as any other antibodies or drugs targeting T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.)
  • have failed for two times or beyond of platinum two drugs chemotherapy (except adjunctive chemotherapy, after which disease relapse or progression within 6 months，has been regarded as first-line therapy.)
  • iconography (CT or MRI) shows obvious lung empty or necrotic tumor
  • patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
  • patients are participating in other clinical studies (other than non-interventional studies) less than 4 weeks from the end of the previous clinical study
Show all 25Show fewer
  • patients who had received chemotherapy, radiation, or other experimental anticancer therapy (except diphosphonate) within 4 weeks prior to the first dose of this study. Those who had previously received local radiotherapy were eligible if they met the following criteria: the end of radiotherapy was more than 4 weeks from the start of this study (brain radiotherapy was more than 2 weeks); In addition, the target lesions selected in this study were not in the radiotherapy area, or if the target lesion is within the radiotherapy area but progression has been confirmed
  • other kinds of malignancies within 5 years or for now
  • patients who have an active, known or suspected autoimmune disease, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, a history of being HIV positive, or a history of acquired immunodeficiency syndrome (AIDS)
  • active or previously recorded inflammatory bowel disease (such as Crohn's disease, ulcerative colitis)
  • have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  • abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
  • have clinical significant hemoptysis occurred within 3 months before enrollment (daily hemoptysis more than half tablespoonl; Or clinical significant bleeding symptoms or bleeding tendency in the 4 weeks prior to grouping, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula, but gastrointestinal perforation or fistula has been surgically removed, admission is allowed), baseline fecal occulted blood ++ or above, unhealed wounds, ulcers or fractures, etc
  • urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
  • uncontrollable hypertensive (SBP≥ 160 mmHg, DBP≥100 mmHg, despite the best drug treatment)
  • patients with severe cardiovascular disease: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; According to NYHA standard, grade III to IV cardiac insufficiency, or echocardiography indicates left ventricular ejection fraction (LVEF) < 50%;
  • patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma
  • Interstitial lung disease, uncontrolled medium to large serosal effusion (including pleural effusion, ascites, and pericardial effusion) after pumping treatment, aggravated chronic obstructive pulmonary disease, active pulmonary infection and/or acute bacterial or fungal respiratory disease requiring intravenous antibiotic treatment within 28 days
  • have an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
  • have venous thromboembolism events within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
  • have received live or attenuated vaccine within 30 days prior to the initial administration of Penpulimab, or was scheduled to receive live or attenuated vaccine during the study
  • patients who have known a history of severe hypersensitivity to other monoclonal antibodies
  • patients who have known a history of psychotropic substance abuse, alcohol abuse, or drug abuse
  • uncontrolled active hepatitis after treatment (Hepatitis B: HBsAg positive and HBV DNA more than 1 x 10^4 copy /ml; Hepatitis C: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection
  • serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nong Yang

    Changsha, Hunan, 410000

Other trials in China

About this study

Official title: Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy: a Single-arm, Multicenter Pilot Study

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase II ALTER1202 trial, patients who failed at least two kinds of systemic chemotherapy regimens (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 4.1 months and 7.3 months, the placebo group PFS and OS were 0.7 months and 4.9 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of sensitive relapsed small-cell lung cancer patients who were failure in the first-line treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

Read the detailed description

This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the effectiveness and safety of Anlotinib Plus Penpulimab in patients with small cell lung cancer after failure of platinum-based chemotherapy.

Eligible patients will receive Anlotinib plus Penpulimab:

Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.

Being tested
Anlotinib Plus Penpulimab
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.

  • Anlotinib Plus PenpulimabDrug

    Also called Anlotinib & Penpulimab

    Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.

Study groups in NCT05001971
Study groupRoleWhat they receive
Anlotinib Plus PenpulimabExperimentalAnlotinib (10mg qd po d1-14, 21 days per cycle) and Penpulimab (200mg ivgtt d1)
Receives: Drug: Anlotinib Plus Penpulimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective Response Rate

    Measured: up to 24 months

Secondary outcomes (4)

  1. PFS

    Progress free survival

    Measured: each 42 days up to PD or death (up to 24 months)

  2. OS

    Overall Survival

    Measured: From randomization until death (up to 24 months)

  3. DCR

    Disease Control Rate

    Measured: each 42 days up to intolerance the toxicity or PD or death (up to 24 months)

  4. Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability）

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Until 21 day safety follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start30 Jan 2021
  3. Primary completion21 Jan 2025
  4. Study completion15 Apr 2025

Resources

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05001971
Sponsor's protocol ID
ALTER-L041
Status last verified
Jan 2026
First submitted
29 Jan 2021
Last updated
15 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • Zeng L, Tian F, Wang C, Chen Q, Jiang W, Liang J, Tan Y, Yan H, Huang J, Zhou C, Yang H, Ruan Z, Huang Z, Dai J, Feng Y, Xiong Y, Liu L, Zhou C, Xu Q, Xie Y, Zhang C, Guo H, Zhang B, Wu Z, Yang N, Zhang Y. Efficacy and biomarker exploration of anlotinib plus penpulimab in second-line ES-SCLC: Results from the phase 2 ALTER-L041 trial. Cell Rep Med. 2026 Aug 18;7(8):102931. doi: 10.1016/j.xcrm.2026.102931. Epub 2026 Jul 22.

    PubMed 42486095

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib Plus Penpulimab in people with Small Cell Lung Cancer, run by Hunan Cancer Hospital at 1 site in China.

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 25 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: finished, as of the sponsor's last update on 15 Jan 2026. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ORR (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05001971, which also lists 1 linked publication.

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 15 Jan 2026.

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