Progression Free Survival(PFS)Phase 2NCT05685550

Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study

A Phase 2 study testing Toposide capsules combined with Anlotinib and Envafolimab group in people with Progression Free Survival(PFS), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Progression Free Survival(PFS)
What is being tested?: Toposide capsules combined with Anlotinib and Envafolimab group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 12 Apr 2023to 31 May 2026
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

4.1.1. Patients with extensive small cell lung cancer confirmed histologically or cytologically;
4.1.2. Has not received systemic antitumor therapy for small cell lung cancer. If the subject receives adjuvant therapy after completing radical therapy for early small cell lung cancer and the subject relapses the disease, ensure that the interval between the end of adjuvant therapy and the first administration of the study is more than 6 months, and that all toxic reactions caused by adjuvant therapy have recovered (Class 1 according to CTCAE v4.0 criteria, except hair loss).
4.1.3. Male or female ≥65 years old and signed informed consent;
4.1.4. The ECOG performance status ≤3, and the expected survival is greater than 6 months;
4.1.5. There must be at least one measurable target lesion (according to RECIST 1.1).
4.1.6. Good organ function: Laboratory tests meet the following requirements: neutrophil absolute value (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L, white blood cell ≥3.0×10^9/L; Liver function: total bilirubin < 1.5 times the upper limit of normal value, AST/SGOT, ALT/SGPT and alkaline phosphatase (ALP) < 2.5 times the upper limit of normal value; If liver metastasis occurs, AST and ALT≤5.0 times the upper limit of normal value; For liver and/or bone metastases, ALP≤5.0 times the upper limit of normal. Renal function: serum creatinine (Scr) ≤1.5 times the upper limit of normal; Urine protein < 2 (+) was detected by routine urine test. If urine protein ≥2 (+) at baseline, 24-hour urine protein quantity must be ≤1.0 g; Coagulation function: International standardized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 times the upper limit of normal value;
4.1.7. Cardiac function: left ventricular ejection fraction (LVEF) ≥50%;
4.1.8 Be able to communicate well with the investigator and follow the study requirements for visits, treatment, laboratory tests and other relevant regulations.

Who cannot join

4.2.1. Previous anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug therapy specifically targeting T-cell costimulation or checkpoint pathways;
4.2.2. With active pinimeningeal disease or poorly controlled and untreated brain metastases:
Note: Patients with a history of central nervous system metastasis and stable at screening are eligible for admission only if they meet all of the following criteria:
Brain imaging at screening showed no evidence of progression, clinically stable for at least 2 weeks, and no evidence of new brain metastases;
Has a measurable and/or evaluable disease outside the central nervous system;
Corticosteroids are not currently required to treat central nervous system diseases; Steroid discontinuation 3 days prior to initial study treatment; Stable doses of anticonvulsants are permitted;

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No stereotactic radiation or whole brain radiotherapy was performed within 14 days prior to the first study treatment;
4.2.3. Patients with active autoimmune disease or a history of autoimmune disease that may recur;
Note: Patients with the following diseases are not excluded for further screening:
Well-controlled type 1 diabetes mellitus;
Hypothyroidism (if controlled with hormone replacement therapy alone);
Well-controlled celiac disease;
Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia);
Any other disease that is not expected to recur in the absence of an external trigger;
4.2.4. There were any active malignancies within 2 years prior to the first administration of the study drug, except for the specific cancers being studied in this study and locally recurring cancers that have been cured (e.g. resected basal cell or squamous cell skin cancer, superficial bladder cancer, breast cancer in situ).
4.2.5. Any condition requiring systemic corticosteroid therapy (doses greater than 10 mg/ day of prednisone or equivalent) or other immunosuppressant treatment within 14 days prior to the first administration of the study drug.
Note: Patients who are currently using or have previously used any of the following steroid regimens may be enrolled:
Adrenalin substitute steroid (prednisone ≤10mg/d or equivalent dose of similar drugs);
Minimal systemic uptake of local, ocular, intra-articular, intranasal, and inhaled corticosteroids. c. Short-term (≤7 days) use of corticosteroids for prevention (e.g., allergy to contrast media) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity caused by contact allergens).
4.2.6. The presence of poorly controlled diabetes mellitus, abnormal laboratory results of potassium, sodium, or corrected calcium > grade 1, or ≥ grade 3 hypoalbuminemia in the 14 days preceding and including the first administration of the study drug.
4.2.7. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (2 weeks after intervention Internal recurrence).
4.2.8. The presence of interstitial lung disease, non-infectious pneumonia or poorly controlled lung diseases (including pulmonary fibrosis, Acute lung disease) history. Patients with significantly impaired lung function or who require oxygen at baseline must be evaluated for lung function at screening.
4.2.9. Had an infection (including tuberculosis, etc.) requiring systemic antibacterial, antifungal or antiviral treatment within 14 days prior to the first administration of the study drug.
Note: Patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are allowed to receive antiviral therapy.
4.2.10. Chronic HBV carriers with untreated chronic hepatitis B or HBV DNA> 500 IU/mL (> 2500 copies /mL) were present at screening.
Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL or < 2500 copies /mL) could be enrolled. Patients who are HBsAg positive or have detectable HBV DNA should be managed according to treatment guidelines. Patients who were receiving antiviral therapy at the time of screening should be treated for > 2 weeks prior to enrolling.
4.2.11. Patients with active hepatitis C.
Note: Patients who tested negative for HCV antibodies at screening or who tested positive for HCV antibodies at screening but subsequently tested negative for HCV RNA were enrolled. HCV RNA testing will only be performed in patients who test positive for HCV antibodies. Patients who were receiving antiviral therapy at the time of screening should be treated for > 2 weeks prior to enrolling.
4.2.12. Known history of HIV infection.
4.2.13. Any major surgical procedures were performed within 28 days prior to the first administration of the study drug. Patients must have fully recovered from the toxicity and/or complications of the intervention prior to initial administration of the investigational drug.
4.2.14. Previous allogeneic stem cell transplantation or organ transplantation.
4.2.15. Have any of the following cardiovascular risk factors:
Cardiogenic chest pain, defined as moderate pain with limited instrumental activities of daily living, occurred within 28 days (including 28 days) before the first administration of the drug;
Occurrence of pulmonary embolism within 28 days (including 28 days) prior to the first administration of the study drug;
The study had acute myocardial infarction within 6 months (including 6 months) before the first administration of the drug;
A history of New York Heart Association (NYHA) Class III or IV heart failure within 6 months including 6 months prior to initial administration of the drug;
Study the occurrence of grade 2 or greater ventricular arrhythmias within 6 months (including 6 months) prior to initial drug administration;
Cerebrovascular accidents occurred within 6 months (including 6 months) before the first administration of the study drug;
Study the presence of poorly controlled hypertension treated with standard antihypertensive drugs within 28 days (including 28 days) prior to initial drug administration;
Study any syncope or seizures within 28 days (including 28 days) prior to initial administration of the drug;
4.2.16. History of severe hypersensitivity to other monoclonal antibodies.
4.2.17. Patients who have previously received systemic therapy (prior adjuvant or neoadjuvant therapy is allowed) or have received any immunotherapy (e.g., interleukin, interferon, thymosin, etc.) or any experimental therapy within 14 days or 5 half-lives prior to the first administration of the study drug, whichever is the older. Or received palliative radiotherapy or other local treatment within 14 days before the study drug was first administered.
4.2.18. Toxicity from previous antitumor therapy has not returned to baseline or stabilized (except for adverse events unlikely to pose a safety risk, such as hair loss, neuropathy or abnormal results of specific laboratory tests).
4.2.19. Live vaccine was administered within 28 days (including 28 days) prior to the first administration of the study drug.
Note: Seasonal influenza vaccines are usually inactivated and are permitted for use. The vaccine used in the nasal cavity is a live vaccine and should not be used.
4.2.20. There are underlying medical conditions (including abnormal laboratory results), alcohol or drug abuse or dependence that adversely affect study drug administration, or affect the interpretation of drug toxicity or AE, or lead to inadequate compliance with study execution.
4.2.21. Pregnant or lactating women.
4.2.22. Also participate in another therapeutic clinical trial.
Note: Participation in both observational and non-interventional studies is permitted. In addition, patients who have completed drug therapy in clinical studies and are in the follow-up period are eligible for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Cancer Hospital Airport Hospital
Tianjin, 300450

Other trials in China

About this study

This study aims to explore the safety and efficacy of etoposide capsules combined with Anlotinib and Envafolimab in elderly patients with extensive small cell lung cancer.This is a single-center, single-arm exploratory clinical study. 30 patients with extensive small-cell lung cancer are scheduled to be enrolled. Treatment regimen is etoposide capsule 100mg PO qd*7d, Anlotinib 12mg PO qd*14d, Envafolimab 300mg/ IH Q3W. Based on the safety and other data from the subjects, the combination regimen was administered for 4 to 6 cycles, with a maximum of 6 cycles. In principle, at least 4 cycles were required unless chemotherapy-related toxicity necessitated early termination. Subsequently, patients without evidence of disease progression received maintenance therapy with envolumab plus anlotinib until disease progression, intolerable adverse events, or death.

Read the detailed description

The primary objective of this study was to explore the safety and median PFS of etoposide capsules combined with Anlotinib and Envafolimab as first-line treatment in elderly patients with extensive small-cell lung cancer (as assessed by the investigators according to RECIST 1.1 criteria).The secondary objective of this study was to evaluate the OS, ORR, and QOL of etoposide capsules combined with Envafolimab and Anlotinib as first-line treatment in elderly patients with extensive small-cell lung cancer.Exploratory aims are to explore predictive or prognostic biomarkers (tissue and/or plasma) associated with therapeutic response or resistance to disease; Analysis of potential biomarkers in biopsy tissue samples and blood samples after disease progression to explore possible mechanisms of therapeutic resistance. To provide a better treatment plan for elderly patients with extensive small cell lung cancer.

Conditions: Progression Free Survival(PFS)
Being tested: Toposide capsules combined with Anlotinib and Envafolimab group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Toposide capsules combined with Anlotinib and Envafolimab groupDrug
Also called Combined treatment group
Elderly patients with extensive SCLC were given etoposide capsules 100mg PO qd*7d and Envafolimab 300mg/ time IH Q3W in combination with Anlotinib 12mg PO qd*14d. Based on the safety and other data from the subjects, the combination regimen was administered for 4 to 6 cycles, with a maximum of 6 cycles. In principle, at least 4 cycles were required unless chemotherapy-related toxicity necessitated early termination. Subsequently, patients without evidence of disease progression received maintenance therapy with Envafolimab plus Anlotinib until disease progression, intolerable adverse events, or death.

Study groups in NCT05685550
Study group	Role	What they receive
Treatment group	Experimental	Etoposide capsules in combination with Anlotinib and Envafolimab Receives: Drug: Toposide capsules combined with Anlotinib and Envafolimab group

What is being measured

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

PFS (Progression-Free-Survival)
The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.
Measured: 30 months

Secondary outcomes (4)

OS (Overall survival time)
The time of death from all causes for all patients from the date of randomization.The efficacy of this study was determined according to Recist version 1.1 criteria.
Measured: 30 months
ORR (Objective response rate)
Defined as complete response and partial response (CR+PR).The efficacy of this study was determined according to Recist version 1.1 criteria.
Measured: 30 months
QOL (Quality of Life) assessed by the QLQ-C30 scale
It mainly refers to the state assessment of individual physiological, psychological and social functions, namely, health quality. The quality of life was assessed by the QLQ-C30 scale
Measured: 30 months
The Adverse Events
AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment. Safety assessment in this study was conducted by the investigator in accordance with the definition of NCI-CTC version 3.0.
Measured: 30 months

Timeline

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

12 Apr 202331 May 2026

First posted17 Jan 2023
Study start12 Apr 2023
Primary completion31 Dec 2025
Study completion31 May 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Progression Free Survival(PFS)Studies of the same condition, open and under way.
More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05685550
Sponsor's protocol ID: JS-2022-0048
Status last verified: Feb 2026
First submitted: 3 Jan 2023
Last updated: 5 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study
ClinicalTrials.gov ID: NCT05685550
Acronym / sponsor ID: JS-2022-0048
Conditions: Progression Free Survival(PFS)
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Study start: 12 Apr 2023 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 May 2026 (estimated)
First posted: 17 Jan 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment group	Experimental	Drug: Toposide capsules combined with Anlotinib and Envafolimab groupEtoposide capsules in combination with Anlotinib and Envafolimab

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

4.1.1. Patients with extensive small cell lung cancer confirmed histologically or cytologically;
4.1.2. Has not received systemic antitumor therapy for small cell lung cancer. If the subject receives adjuvant therapy after completing radical therapy for early small cell lung cancer and the subject relapses the disease, ensure that the interval between the end of adjuvant therapy and the first administration of the study is more than 6 months, and that all toxic reactions caused by adjuvant therapy have recovered (Class 1 according to CTCAE v4.0 criteria, except hair loss).
4.1.3. Male or female ≥65 years old and signed informed consent;
4.1.4. The ECOG performance status ≤3, and the expected survival is greater than 6 months;
4.1.5. There must be at least one measurable target lesion (according to RECIST 1.1).

Key exclusion criteria (49 listed)

4.2.1. Previous anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug therapy specifically targeting T-cell costimulation or checkpoint pathways;
4.2.2. With active pinimeningeal disease or poorly controlled and untreated brain metastases:
Note: Patients with a history of central nervous system metastasis and stable at screening are eligible for admission only if they meet all of the following criteria:
Brain imaging at screening showed no evidence of progression, clinically stable for at least 2 weeks, and no evidence of new brain metastases;
Has a measurable and/or evaluable disease outside the central nervous system;

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
Toposide capsules combined with Anlotinib and Envafolimab groupAlso: Combined treatment groupElderly patients with extensive SCLC were given etoposide capsules 100mg PO qd7d and Envafolimab 300mg/ time IH Q3W in combination with Anlotinib 12mg PO qd14d. Based on the safety and other data from the subjects, the combination regimen was administered for 4 to 6 cycles, with a maximum of 6 cycles. In principle, at least 4 cycles were required unless chemotherapy-related toxicity necessitated early termination. Subsequently, patients without evidence of disease progression received maintenance therapy with Envafolimab plus Anlotinib until disease progression, intolerable adverse events, or death.	Drug	Treatment group

Primary outcome

PFS (Progression-Free-Survival)
Time frame: 30 months
The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.

4 secondary outcomes

OS (Overall survival time)
Time frame: 30 months
ORR (Objective response rate)
Time frame: 30 months
QOL (Quality of Life) assessed by the QLQ-C30 scale
Time frame: 30 months
The Adverse Events
Time frame: 30 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 5 Feb 2026.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 49 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 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?

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?

PFS (Progression-Free-Survival) (time frame: 30 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 NCT05685550.

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 5 Feb 2026.