UnknownPhase 3

The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.

China486 participantsStarted 2021-01-22

Plain-language summary

The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female, 18-75 years of age.
✓. Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
✓. ECOG PS 0\~1.
✓. At least 1 measurable lesion as defined by RECIST v1.1.
✓. Adequate organ function.
✓. Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
✓. Signed the informed consent form.

✕. Mixed SCLC or NSCLC.
✕. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
✕. Extensive-stage SCLC.
✕. Subjects who is surgically resectable.
✕. Subjects with malignant pleural effusion.
✕. Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
✕. Active, known, or suspected autoimmune diseases.
✕. History of malignant tumors.

Timeframe: up to 36 months

NCT IDNCT04691063

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-15

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female, 18-75 years of age.
✓. Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
✓. ECOG PS 0\~1.
✓. At least 1 measurable lesion as defined by RECIST v1.1.
✓. Adequate organ function.
✓. Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
✓. Signed the informed consent form.

✕. Mixed SCLC or NSCLC.
✕. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
✕. Extensive-stage SCLC.
✕. Subjects who is surgically resectable.
✕. Subjects with malignant pleural effusion.
✕. Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
✕. Active, known, or suspected autoimmune diseases.
✕. History of malignant tumors.