SCLC, Extensive StagePhase 1NCT07413042
A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizumab in the Maintenance Treatment Period for Patients of Extensive-stage Small Cell Lung Cancer (ES-SCLC) With Somatostatin Receptors (SSTR)+ as First-line Treatment
A Phase 1 study testing [225Ac]Ac-DOTATATE in people with SCLC, Extensive Stage, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This is a phase I study to evaluate the safety and preliminary efficacy of [225Ac]Ac-DOTATATE injection combined with tislelizumab in the maintenance treatment period for patients of extensive-stage small cell lung cancer (ES-SCLC) with somatostatin receptors (SSTR)+ as first-line treatment.Patients with ES-SCLC who… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SCLC, Extensive Stage
- What is being tested?
- [225Ac]Ac-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Jun 2028
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the ability to understand and sign an approved informed consent form (ICF).
- Patients must be >= 18 and <＝80 years of age.
- Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.
- Presence of at least 1 measurable site of disease (based on RECIST 1.1).
- ECOG score of 0 or 1.
- SSTR-PET positive.
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- Sufficient bone marrow capacity and organ function:
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (Cockcroft Gault formula).
- Hemoglobin≥90g/L, neutrophil count ≥1.5×10^9/L, platelets≥100×10^9/L. Serum total bilirubin ≤1.5×ULN. Serum albumin ≥30g/L. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN，or ALT/AST≤5×ULN with liver metastases.
- Partially activated prothrombin time (APTT) ≤1.5 x ULN.
- Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 6 months of the last use of the trial drug.
Who cannot join
- Pregnant or lactating females.
- Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
- Uncontrolled congestive heart failure.
- uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.
- Known hypersensitivity to Lutetium[177Lu] Oxodotreotide Injection or [225Ac]Ac-DOTATATE Injection and their excipients.
- Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics.
- Unsuitable for the study for any reason, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100000
Zhi Yang, 010-88196196, pekyz@163.com
About this study
This is a phase I study to evaluate the safety and preliminary efficacy of [225Ac]Ac-DOTATATE injection combined with tislelizumab in the maintenance treatment period for patients of extensive-stage small cell lung cancer (ES-SCLC) with somatostatin receptors (SSTR)+ as first-line treatment.Patients with ES-SCLC who have completed the induction therapy of first-line standard treatment and are yet to enter the maintenance treatment period are planned to be enrolled.
- Conditions
- SCLC, Extensive Stage
- Being tested
- [225Ac]Ac-DOTATATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[225Ac]Ac-DOTATATEDrug
During the dose escalation phase, the "3+3" dose escalation method was adopted. There were two dose groups: the single-dose administration dose of the first dose group was 90 kBq/kg, and that of the second dose group was 120 kBq/kg.During the dose expansion phase, the subjects received the RP2D dose of the [225Ac]Ac-DOTATATE injection. The administration method, combination therapy, etc. were all the same as those in the dose escalation phase.
| Study group | Role | What they receive |
|---|---|---|
| [225Ac]Ac-DOTATATE | Experimental | The subjects received the [225Ac]Ac-DOTATATE injection combined with tislelizumab. The tislelizumab was administered at a fixed dose of 200mg on day 1, and was given every 3 weeks. The [225Ac]Ac-DOTATATE injection was administered once every 6 (±1) weeks, with a maximum of 4 administrations. Receives: Drug: [225Ac]Ac-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
Incidence and severity of adverse events (AEs) DLT MTD RP2D
Measured: 6 months after last dose administration
During the dose expansion phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
PFS
Measured: 12 months after last dose administration
Secondary outcomes (9)
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
PFS
Measured: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
ORR
Measured: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
DCR
Measured: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
OS
Measured: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
PFS since the first-line treatment
Measured: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
ORR
Measured: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
DCR
Measured: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
OS
Measured: 12 months after last dose administration
During the dose expansion phase, the safety is evaluated.
Incidence and severity of adverse events (AEs)
Measured: 6 months after last dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start20 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413042
- Sponsor's protocol ID
- IIT-XT024-1-02
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizumab in the Maintenance Treatment Period for Patients of Extensive-stage Small Cell Lung Cancer (ES-SCLC) With Somatostatin Receptors (SSTR)+ as First-line Treatment
- ClinicalTrials.gov ID
- NCT07413042
- Acronym / sponsor ID
- IIT-XT024-1-02
- Conditions
- SCLC, Extensive Stage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Feb 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 is a phase I study to evaluate the safety and preliminary efficacy of [225Ac]Ac-DOTATATE injection combined with tislelizumab in the maintenance treatment period for patients of extensive-stage small cell lung cancer (ES-SCLC) with somatostatin receptors (SSTR)+ as first-line treatment.Patients with ES-SCLC who have completed the induction therapy of first-line standard treatment and are yet to enter the maintenance treatment period are planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [225Ac]Ac-DOTATATE | Experimental | Drug: [225Ac]Ac-DOTATATEThe subjects received the [225Ac]Ac-DOTATATE injection combined with tislelizumab. The tislelizumab was administered at a fixed dose of 200mg on day 1, and was given every 3 weeks. The [225Ac]Ac-DOTATATE injection was administered once every 6 (±1) weeks, with a maximum of 4 administrations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have the ability to understand and sign an approved informed consent form (ICF).
- Patients must be >= 18 and <＝80 years of age.
- Extensive-stage small cell lung cancer that requires histopathological or cytological confirmation.
- Presence of at least 1 measurable site of disease (based on RECIST 1.1).
- ECOG score of 0 or 1.
Key exclusion criteria (7 listed)
- Pregnant or lactating females.
- Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
- Uncontrolled congestive heart failure.
- uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.
- Known hypersensitivity to Lutetium[177Lu] Oxodotreotide Injection or [225Ac]Ac-DOTATATE Injection and their excipients.
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 |
|---|---|---|
| [225Ac]Ac-DOTATATEDuring the dose escalation phase, the "3+3" dose escalation method was adopted. There were two dose groups: the single-dose administration dose of the first dose group was 90 kBq/kg, and that of the second dose group was 120 kBq/kg.During the dose expansion phase, the subjects received the RP2D dose of the [225Ac]Ac-DOTATATE injection. The administration method, combination therapy, etc. were all the same as those in the dose escalation phase. | Drug | [225Ac]Ac-DOTATATE |
Primary outcome
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
Time frame: 6 months after last dose administration
Incidence and severity of adverse events (AEs) DLT MTD RP2D
During the dose expansion phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated.
Time frame: 12 months after last dose administration
PFS
9 secondary outcomes
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
Time frame: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
Time frame: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
Time frame: 12 months after last dose administration
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection for use as a maintenance treatment in the first-line therapy of SSTR-positive ES-SCLC patients when combined with tislelizumab was evaluated.
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
Time frame: 12 months after last dose administration
During the dose expansion phase, other efficacy endpoint indicators will be evaluated.
Time frame: 12 months after last dose administration
During the dose expansion phase, the safety is evaluated.
Time frame: 6 months after last dose administration
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 17 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [225Ac]Ac-DOTATATE in people with SCLC, Extensive Stage, run by Peking University Cancer Hospital & Institute 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Zhi Yang (010-88196196, pekyz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
During the dose escalation phase, the efficacy of [225Ac]Ac-DOTATATE injection at the RP2D dose for maintenance treatment in first-line therapy for SSTR-positive ES-SCLC patients when used in combination with tislelizumab was evaluated. (time frame: 6 months after last dose administration). The study lists 2 primary outcomes in all. 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 17 Feb 2026.