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Status unknownNCT04313660Updated Mar 18, 2020

Anlotinib In Combination With PD-1/L1 Inhibitor As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

A Phase 2 interventional study of Anlotinib In Combination With PD-1/L1 Inhibitor in NSCLC, Anlotinib and PD-1/L1 Inhibitor, sponsored by Xiaorong Dong. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Xiaorong Dong · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Anlotinib In Combination With PD-1/L1 Inhibitor As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

02

Conditions studied

  • NSCLC
  • Anlotinib
  • PD-1/L1 Inhibitor
03

In context

Small Cell Lung Carcinoma

1,201 studies on the registry are indexed under Small Cell Lung Carcinoma; 340 are open to participants now.

This study's planned enrollment of 33 is below the median of 56 across 1,030 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Xiaorong Dong is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up;
  2. Patients between 18-75 years old;
  3. 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];
  4. The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks;
  5. The life expectancy shall be at least 3 months;
  6. ECoG score: 0-1

Exclusion criteria

Exclusion Criteria:

  1. Small cell lung cancer patients with other pathological types of tumor species;
  2. Patients with pathological fracture in bone metastasis of small cell lung cancer;
  3. Patients with central nervous system metastasis;
  4. Patients who have received chest radiotherapy before;
  5. Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before;
  6. 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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    Anlotinib In Combination With PD-1/L1 Inhibitor

    Drug: Anlotinib In Combination With PD-1/L1 Inhibitor

Interventions

  • DrugAnlotinib In Combination With PD-1/L1 Inhibitor

    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.

06

What researchers measure

Primary outcomes

  1. progress free survival(PFS)

    the period from the beginning of treatment to the observation of disease progress or death for any reason

    Time frame: 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

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04313660
Lead sponsor
Xiaorong Dong
Responsible party
Xiaorong Dong (Professor, Wuhan Union Hospital, China) — Sponsor-investigator
First posted
Mar 18, 2020
Start date
Apr 2020 (estimated)
Primary completion
Feb 2021 (estimated)
Completion
Feb 2022 (estimated)
Last update
Mar 18, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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