SHR-A2102 versus investigator's choice chemotherapy for recurrent or metastatic cervical cancer after platinum and PD-(L)1 therapy

An Open-label, Randomized, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer

This trial tests whether SHR-A2102 works better than standard chemotherapy for people with recurrent or metastatic cervical cancer whose disease progressed after platinum-based chemotherapy and PD-(L)1 inhibitors.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07418749 on ClinicalTrials.gov

What this trial studies

This is a randomized Phase 3 trial comparing SHR-A2102 to investigator-selected chemotherapy (pemetrexed, gemcitabine, topotecan, or albumin‑bound paclitaxel) in patients with recurrent or metastatic cervical squamous, adenocarcinoma, or adenosquamous carcinoma after prior platinum and PD-(L)1 inhibitor therapy. Eligible patients must have measurable disease by RECIST 1.1, ECOG performance status 0–1, adequate organ function, and provide tumor tissue samples. Participants are randomized to receive the study drug or physician's choice chemotherapy with regular imaging and clinical assessments to measure tumor response, safety, and survival outcomes. Treatment continues until disease progression, unacceptable toxicity, or other protocol-specified discontinuation criteria.

Who should consider this trial

Good fit: Adults with histologically confirmed recurrent or metastatic cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that progressed after platinum-based chemotherapy and PD-(L)1 inhibitor therapy, with measurable disease, ECOG 0–1, adequate organ function, and expected survival ≥12 weeks are the intended participants.

Not a fit: Patients with untreated or active central nervous system metastases, symptomatic or uncontrolled large effusions, recent or concurrent other malignancies, recent gastrointestinal or urogenital fistula or high fistula risk, or poor performance status are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, SHR-A2102 could provide a more effective treatment option that prolongs tumor control or survival for patients who have exhausted platinum chemotherapy and PD-(L)1 inhibitors.

How similar studies have performed: Previous trials of targeted agents and antibody-drug conjugates in this post-platinum, post–PD-(L)1 setting have shown mixed but sometimes meaningful benefits, so results in this setting remain variable and not yet definitive.

Eligibility criteria

Inclusion Criteria:

1. Participate in the study voluntarily, sign the informed consent form.
2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy.
3. Provide primary or metastatic tumor samples.
4. At least one measurable lesion (RECIST version 1.1).
5. ECOG 0\~ 1.
6. With adequate organ functions.
7. Expected overall survival is ≥12 weeks.

Exclusion Criteria:

1. With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
2. With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
3. With a history of or concurrent other malignant tumor(s).
4. Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
5. With known or suspected interstitial lung disease.
6. With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization.
7. With poorly controlled cardiac clinical symptoms or diseases.
8. Experienced arterial/venous thromboembolic events within 3 months prior to randomization.
9. With severe infections occurring within 1 month prior to randomization.
10. With active hepatitis B (defined as positive hepatitis B surface antigen \[HBsAg\] test and hepatitis B virus \[HBV\] DNA ≥500 IU/mL at screening) or active hepatitis C (defined as positive hepatitis C virus antibody \[HCV-Ab\] test and detectable hepatitis C virus \[HCV\] RNA at screening).
11. With active tuberculosis infection within 1 year prior to randomization, or a history of active tuberculosis infection more than 1 year ago without proper treatment.
12. With a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
13. Have received systemic anti-tumor therapy within 28 days prior to randomization.
14. With uncontrolled psychiatric disorders, or known history of alcoholism, drug abuse, or substance dependence, incarceration, or other conditions that may affect the completion of study procedures.
15. Any other condition that, in the judgment of the investigator, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the participant unsuitable for the study.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhifei Lin

Conditions Recurrent Cervical Cancer; Metastatic Cervical Cancer