ClinicalTrials.gg
Not yet recruitingNCT07895992Updated Oct 26, 2026

SHR-A2009 Combined With Bevacizumab in the Treatment of Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer : a Randomized Controlled, Open, Multicenter Phase III Study

A Phase 3 interventional study of SHR-A2009 + bevacizumab and Sacituzumab Tirumotecan in Non-squamous Non-small Cell Lung Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
490
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined bevacizumab versus Sacituzumab Tirumotecan in the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer

02

Conditions studied

  • Non-squamous Non-small Cell Lung Cancer
03

In context

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 104 studies on the registry; 73 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ; the age at the time of signing the informed consent form is 18-75 years old ( including both ends ), both men and women can.

    The ECOG score was 0 or 1.

  2. Participants with locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology.
  3. Adequate bone marrow and organ function.

Exclusion criteria

Exclusion Criteria:

  1. Anti-tumor therapy such as chemotherapy, biological therapy, targeted therapy, immunotherapy or other unlisted clinical research drugs or treatments were received within 4 weeks before the first medication.
  2. Untreated or active central nervous system tumor metastasis
  3. Imaging showed that the tumor invaded important organs or tumor surrounding / invasion of large blood vessels or there was obvious necrosis / cavity, which was judged by the researchers to have a risk of bleeding.
  4. History of interstitial pneumonia or participants who cannot rule out interstitial pneumonia ; or other moderate to severe lung diseases ; or received previous pneumonectomy surgery
  5. Participants with severe cardiovascular and cerebrovascular diseases
  6. Have a history of severe bleeding tendency or coagulation dysfunction ; bleeding symptoms with significant clinical significance occurred within 3 months before the first medication.
  7. Arterial and venous thrombosis events occurred within 6 months before the first administration ;
  8. HIV test positive
  9. Participants with active hepatitis B or C
  10. Severe infection occurred within 4 weeks before the first administration
  11. Allergy to any component of the treatment regimen
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
490 participants (estimated)

Study arms

  • Experimental
    SHR-A2009 + bevacizumab

    Drug: SHR-A2009 + bevacizumab

  • Active comparator
    Sacituzumab Tirumotecan

    Drug: Sacituzumab Tirumotecan

Interventions

06

What researchers measure

Primary outcomes

  1. PFS

    Time frame: about 24 months

Secondary outcomes

  1. The incidence and grade of adverse events;

    Time frame: about 24 months

  2. OS

    Time frame: about 24 months

  3. ORR

    Time frame: about 24 months

  4. DoR

    Time frame: about 24 months

  5. DCR

    Time frame: about 24 months

07

Study locations

1 site
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510080, China
    • Yilong Wu · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895992
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Dec 30, 2028 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Oct 26, 2026

Study contacts

Yijing Chen
Contact
yijing.chen.yc510@hengrui.com
18810456365

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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