AnlotinibPhase 2NCT04314297
Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
A Phase 2 study testing Anlotinib In Combination With Durvalumab in people with Anlotinib and Durvalumab, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anlotinib, Durvalumab, Small Cell Lung Cancer
- What is being tested?
- Anlotinib In Combination With Durvalumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Feb 2022
- 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
- The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; Patients between 18-75 years old; Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide [complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard]; The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks; The life expectancy shall be at least 3 months; ECoG score: 0-1
Who cannot join
- Small cell lung cancer patients with other pathological types of tumor species; Patients with pathological fracture in bone metastasis of small cell lung cancer; Patients with central nervous system metastasis; Patients who have received chest radiotherapy before; Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
About this study
Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
- Conditions
- Anlotinib, Durvalumab, Small Cell Lung Cancer
- Being tested
- Anlotinib In Combination With Durvalumab
- 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 In Combination With DurvalumabDrug
At the end of chest radiotherapy (c2d1), the simultaneous administration of androtinib hydrochloride capsule and PD-1 / L1 inhibitor was started. L
Arotinib hydrochloride capsule, 12 mg, Po, QD, was taken orally for two weeks, one week, three weeks as a cycle, completed in the first 14 days until the disease progress;
Durvalumab injection, 1500mg, IV, once every three weeks, completed on the first day until the disease progresses.
Tetraprizumab injection, 240mg, IV, once every three weeks, completed on the first day until the disease progresses.
The choice of durvalumab / trepril mAb was at the discretion of the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib In Combination With Durvalumab | Experimental | Not described Receives: Drug: Anlotinib In Combination With Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival(PFS)
the period from the beginning of treatment to the observation of disease progress or death for any reason
Measured: 1 year
Secondary outcomes (1)
Overall survival(OS)
Time from randomization to death for any reason. The last follow-up time is usually calculated as the time of death for the subjects who have lost the visit before death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnlotinibStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314297
- Sponsor's protocol ID
- AVATAR 2
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
- ClinicalTrials.gov ID
- NCT04314297
- Acronym / sponsor ID
- AVATAR 2
- Conditions
- Anlotinib, Durvalumab, Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 19 Mar 2020 (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.
Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib In Combination With Durvalumab | Experimental | Drug: Anlotinib In Combination With Durvalumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; Patients between 18-75 years old; Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide [complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard]; The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks; The life expectancy shall be at least 3 months; ECoG score: 0-1
Key exclusion criteria (1 listed)
- Small cell lung cancer patients with other pathological types of tumor species; Patients with pathological fracture in bone metastasis of small cell lung cancer; Patients with central nervous system metastasis; Patients who have received chest radiotherapy before; Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
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 |
|---|---|---|
| Anlotinib In Combination With DurvalumabAt the end of chest radiotherapy (c2d1), the simultaneous administration of androtinib hydrochloride capsule and PD-1 / L1 inhibitor was started. L Arotinib hydrochloride capsule, 12 mg, Po, QD, was taken orally for two weeks, one week, three weeks as a cycle, completed in the first 14 days until the disease progress; Durvalumab injection, 1500mg, IV, once every three weeks, completed on the first day until the disease progresses. Tetraprizumab injection, 240mg, IV, once every three weeks, completed on the first day until the disease progresses. The choice of durvalumab / trepril mAb was at the discretion of the researchers. | Drug | Anlotinib In Combination With Durvalumab |
Primary outcome
progress free survival(PFS)
Time frame: 1 year
the period from the beginning of treatment to the observation of disease progress or death for any reason
1 secondary outcome
Overall survival(OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib In Combination With Durvalumab in people with Anlotinib and Durvalumab, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. 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?
Results are not available in the source record.
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?
progress free survival(PFS) (time frame: 1 year). 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 19 Mar 2020.