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Trial Radar IA
Lo studio clinico NCT06734182 (neovision) per Carcinoma polmonare non a piccole cellule è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer (neovision) Fase II 25 Multicentrico

In arruolamento
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La sperimentazione clinica NCT06734182 (neovision) è uno studio interventistico di Fase II volto a esaminare il trattamento per Carcinoma polmonare non a piccole cellule, attualmente in arruolamento. Avviato il 22 giugno 2024, prevede di arruolare 25 partecipanti. Sotto la guida di Guangdong Provincial People's Hospital, dovrebbe concludersi entro il 22 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 16 dicembre 2024.
Sommario breve
This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Envafolimab injection (PD-L1) combined with Disitamab Vedotin (HER2 ADC) and Carboplatin for resectable, HER2-Mutant, stage II-IIIB, NSCLC.
Descrizione dettagliata
The eligible patients will receive 4 cycles of subcutaneous Envafolimab injections (300mg, d1, Q3W) in combination with intravenous Disitamab Vedotin (2.5mg/kg, d1, Q3W) and carboplatin (AUC5, d1, Q3W), followed by surgical resection 4-6 weeks after the last dose of neoadjuvant therapy. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for evaluat...Mostra di più
Titolo ufficiale

A Prospective, Single-arm, Multicenter, Phase II Clinical Study on Envafolimab Combined With Disitamab Vedotin And Carboplatin for Resectable, Stage II-III, HER2-Mutant Non-Small Cell Lung Cancer

Patologie
Carcinoma polmonare non a piccole cellule
Altri ID dello studio
  • neovision
  • SMA-NSCLC-013
Numero NCT
NCT06734182
Data di inizio (effettiva)
2024-06-22
Ultimo aggiornamento pubblicato
2024-12-16
Data di completamento (stimata)
2028-06-22
Arruolamento (previsto)
25
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Parole chiave
Stage II-IIIB
HER2-Mutant
Non-small Cell Lung Cancer
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleIntervention/Treatment
Patients were treated with subcutaneous Envafolimab injections (300mg, d1, Q3W) combined with intravenous Disitamab Vedotin (2.5mg/kg, d1, Q3W) and carboplatin (AUC5, d1, Q3W) Participants receive totally 4 cycles of Envafolimab combined with Disitamab Vedotin and carboplatin during perioperative period
Envafolimab injections+intravenous Disitamab Vedotin+carboplatin
Biological: Envafolimab 300 mg by subcutaneous injections every 3 weeks (Q3W), given on cycle day 1; Biological: Disitamab Vedotin 2.5mg/kg by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;
Esito primario
Misure di esitoDescrizione della misuraArco temporale
MPR rate
Major Pathological Response (MPR) Rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.
up to 7 weeks after neoadjuvant
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
pCR rate
Pathological Complete Response (pCR) Rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
pCR:up to 7 weeks after neoadjuvant;
ORR
Objective Response Rate (ORR) is defined as the percentage of participants achieving complete response (CR) and partial response (PR) for tumor volume reduction and maintaining the minimum duration requirement based on RECIST v1.1
ORR:up to 7 weeks after neoadjuvant;
EFS
Event Free Survival (EFS) is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
EFS up to 3 years
OS
Overall survival (OS) is defined as the time from randomization until death from any cause.
OS up to 3 years
Safety evaluation of subjects
Safety: adverse event (AE), abnormal laboratory examination, serious adverse event (SAE) related with the study drug judged using NCI-CTCAE V5.0; surgical feasibility: percentage of procedure delay or cancellation, change of surgical approach, operation time, Incidence of surgical complications；
Safety: 90 days after the last administration
Molecular progression of ctDNA based on MRD monitoring
Molecular progression of ctDNA, defined as the time at which ctDNA mutations were first detected during postoperative MRD haemodynamic monitoring.
up to 3 years
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  1. Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
  2. Aged 18-75 years, male or female;
  3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; N2 should be confirmed by mediastinoscopy or EBUS.
  4. PET-CT or CT plus MRI should be completed before enrollment;
  5. HER2 mutations identified by histological specimens;
  6. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1);
  7. Tumor tissue specimens and blood sample available for detection of MRD and biomarkers (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment);
  8. ECOG score 0-1;
  9. No contraindications to immunotherapy;
  10. Adequate organ function:
  11. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;
  12. Pulmonary function being able to withstand the planned surgery evaluated by surgeons;
  13. Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug

  1. Presence of locally advanced, unresectable or metastatic disease; unresectable includes the unresectable defined in the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019), including partial stage IIIA and IIIB and all the stage IIIC;
  2. Participants with known EGFR sensitive mutations or ALK translocation, KRAS sensitive mutations, BRAF V600E, ROS1 fusions, RET fusions, MET exon 14 alterations and MET amplification, NTRK fusions;
  3. Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product;
  4. History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis/interstitial lung disease requiring steroid treatment;
  5. Active tuberculosis;
  6. Active infection requiring systemic treatment;
  7. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
  8. Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen \[HBsAg\] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay <500 IU/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody \[HCsAb\] in screening period and positive HCV-RNA);
  9. Known human immunodeficiency virus (HIV) infection (known positive HIV antibody);
  10. Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed);
  11. Previous use of PD-1/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40);
  12. Severe allergic reaction to other monoclonal antibodies;
  13. Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months;
  14. Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival > 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded
Guangdong Provincial People's Hospital logoGuangdong Provincial People's Hospital
Contatti principali dello studio
Contatto: Wenzhao Zhong, 020-83525975, [email protected]
1 Centri dello studio in 1 paesi
Guangdong Provincial People's Hospital, Guangzhou, China
Wenzhao Zhong, Contatto
In arruolamento