A Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
A Open-label, Single-arm, Phase II Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hongqing Zhuang, Doctor
- Numéro de téléphone: 010-82264931
- E-mail: hongqingzhuang@163.com
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100191
- Peking University Third Hospital
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Contact:
- Hongqing Zhuang, Doctor
- E-mail: hongqingzhuang@163.com
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Chercheur principal:
- Hongqing Zhuang, Doctor
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Beijing, Beijing, Chine, 100142
- Beijing Cancer Hospital
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Contact:
- Huiming Yu, Doctor
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Chercheur principal:
- Huiming Yu, Doctor
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Shanghai
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Shanghai, Shanghai, Chine, 200040
- Huashan Hospital Fudan University
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Contact:
- Enmin Wang, Doctor
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Chercheur principal:
- Enmin Wang, Doctor
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Tianjin
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Tianjin, Tianjin, Chine, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Contact:
- Zhiyong Yuan, Doctor
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Chercheur principal:
- Zhiyong Yuan, Doctor
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.
2. Histologically or pathologically confirmed advanced non-small cell lung cancer.
3. Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.
4. Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.
5. Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
7.Understood and Signed an informed consent form.
Exclusion Criteria:
1. Has used against PD-1, PD-L1 and other related immunotherapeutic drugs. 2.Has mutations in (epidermal growth factor receptor)EGFR, (anaplastic lymphoma kinase)ALK, (c-ros oncogene 1 receptor kinase)ROS1 or T790M and not resistant to targeted drug.
3. Has severe hypersensitivity reaction to other monoclonal antibodies. 4. Has diagnosed and/or treated additional malignancy within 5 years prior to the first administration.Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.
5. Has any active autoimmune disease or a history of autoimmune disease. 6. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
7. (Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.
8. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
9. Has any severe and/or uncontrolled disease. 10. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
11. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: TQB2450+SBRT
SBRT three days before TQB2450.
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TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.
Give according to the location of the lesion and clinical condition.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS)
Délai: Baseline up to 96 weeks
|
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
|
Baseline up to 96 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Objective response rate (ORR)
Délai: Baseline up to 96 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR).
|
Baseline up to 96 weeks
|
|
Overall survival (OS)
Délai: Baseline up to 96 weeks
|
OS defined as the time from the first dose to death from any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
|
Baseline up to 96 weeks
|
|
Disease control rate（DCR）
Délai: Baseline up to 96 weeks
|
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
|
Baseline up to 96 weeks
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TQB2450-II-05
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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