Eine zweiarmige (Phase 2) explorative Studie zur Nivolumab-Monotherapie oder in Kombination mit Nab-Paclitaxel und Carboplatin bei NSCLC im Frühstadium in China
Nivolumab (BMS-936558) ist ein vollständig humaner mAb vom IgG4-Isotyp (Kappa), der PD-1 an aktivierten Immunzellen bindet und die Bindung des Rezeptors an seine Liganden PD-L1 (B7 H1/CD274) und PD-L2 (B7 -DC/CD273), wodurch hemmende Signale aufgehoben und die Antitumorreaktion des Wirts verstärkt werden. In frühen klinischen Studien zeigte Nivolumab Wirksamkeit bei mehreren Tumorarten, darunter Melanom, Nierenzellkarzinom (RCC) und nicht-kleinzelliger Lungenkrebs (NSCLC).
Nivolumab befindet sich in der klinischen Entwicklung zur Behandlung von Patienten mit NSCLC, RCC, Melanom, Plattenepithelkarzinom des Kopfes und Halses (SCCHN) und anderen Tumoren (z. B. Glioblastoma multiforme, Mesotheliom, kleinzelliger Lungenkrebs, Magenkrebs).
Nivolumab ist in den Vereinigten Staaten (USA), der Europäischen Union und anderen Ländern für die Behandlung von Patienten mit inoperablem oder metastasiertem Melanom, fortgeschrittenem NSCLC mit Progression unter oder nach platinbasierter Chemotherapie, fortgeschrittenem RCC, dessen Krankheit unter einer antiangiogenen Therapie fortschritt, zugelassen. klassisches Hodgkin-Lymphom, das nach einer autologen hämatopoetischen Stammzelltransplantation und einer Brentuximab-Vedotin-Behandlung nach der Transplantation rezidiviert oder fortgeschritten ist, und rezidivierendes oder metastasiertes Plattenepithelkarzinom des Kopfes und Halses mit Krankheitsprogression während oder nach einer platinbasierten Therapie.
Die vorgeschlagene Studie wird die Wirksamkeit und Sicherheit der präoperativen Verabreichung von Nivolumab oder Nivolumab in Kombination mit Nab-Paclitaxel und Carboplatin im neoadjuvanten Umfeld und der Verabreichung von Nivolumab im adjuvanten Umfeld bei Patienten mit resektablem NSCLC mit hohem Risiko bewerten und eine umfassende explorative Charakterisierung ermöglichen die Mikroumgebung des Tumorimmunsystems und die zirkulierenden Immunzellen dieser Patienten. Die in dieser Studie gewonnenen Daten werden wertvolle Informationen für die Planung weiterer prospektiver klinischer Studien mit Anti-PD-1- und anderen Immuntherapien bei NSCLC liefern, sowohl im perioperativen Bereich als auch im fortgeschrittenen Krankheitsstadium. Letztendlich ist es äußerst wünschenswert, potenzielle Biomarker für das Ansprechen und die Toxizität zu entdecken, um Patienten mit NSCLC, die am wahrscheinlichsten davon profitieren, eine Anti-PD-1-Behandlung zu ermöglichen und umgekehrt das Risiko einer Toxizität und einer ineffektiven Behandlung für Patienten zu minimieren, bei denen dies der Fall ist wahrscheinlich nicht davon profitieren.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Frühstadium IB-IIIA, operabler nicht-kleinzelliger Lungenkrebs, im Gewebe bestätigt
- Lungenfunktionsfähigkeit, die die geplante Lungenoperation tolerieren kann
- Leistungsstatus der Eastern Cooperative Oncology Group (ECOG) von 0-1
- Verfügbares Gewebe des primären Lungentumors
Ausschlusskriterien:
- Vorliegen einer lokal fortgeschrittenen, inoperablen oder metastasierten Erkrankung
- Teilnehmer mit aktiver, bekannter oder vermuteter Autoimmunerkrankung
- Vorherige Behandlung mit einem Medikament, das auf T-Zell-Kostimulationswege abzielt (z. B. Checkpoint-Inhibitoren)
Es könnten andere im Protokoll definierte Einschluss-/Ausschlusskriterien gelten
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Part 1: Nivolumab Mono
In arm A, 24 participants will be enrolled into this arm according to PD-L1 expressing level (≥50%).Arm A consists of 3 cycles of neoadjuvant nivolumab (360mg every 3 weeks), and adjuvant nivolumab (360mg IV, every 3 weeks) up to 12 months
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Nivolumab 360 mg IV (administered intravenously for more than 30 minutes) every 3 weeks
Including lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
Segmentectomy and wedge resection are not permitted.
Within 6 weeks after definitive surgery, subjects in each cohort who are assessed to have benefited from neoadjuvant therapy (CR, PR, or SD) and have adequately recovered from surgery may receive adjuvant nivolumab (360 mg via IV infusion over at least 30 minutes, every 3 weeks) for up to 12 months, or until disease recurrence or unacceptable toxicity.
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Experimental: Part 1: Nivolumab Plus Chemo
In arm B, up to 12 participants will be enrolled into each subgroup according to PD-L1 expressing level (<1% and 1%-49%).arm
B consists of 3 cycles of neoadjuvant nivolumab (360mg every 3 weeks) with nab-paclitaxel and carboplatin(nab-paclitaxel 135 mg/m2, d1, 8 and carboplatin AUC 5, d1 every three weeks ), and adjuvant nivolumab (360mg IV, every 3 weeks) up to 12 months
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AUC 5, d1 alle drei Wochen
135 mg/m2, d1, 8
Nivolumab 360 mg IV (administered intravenously for more than 30 minutes) every 3 weeks
Including lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
Segmentectomy and wedge resection are not permitted.
Within 6 weeks after definitive surgery, subjects in each cohort who are assessed to have benefited from neoadjuvant therapy (CR, PR, or SD) and have adequately recovered from surgery may receive adjuvant nivolumab (360 mg via IV infusion over at least 30 minutes, every 3 weeks) for up to 12 months, or until disease recurrence or unacceptable toxicity.
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Experimental: Part:2: Exploratory cohort
In part 2，the treatment regimen consists of three cycles of neoadjuvant nivolumab (360 mg every 3 weeks) in combination with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m² on days 1 and 8, and carboplatin AUC 5 on day 1, every 3 weeks), followed by adjuvant nivolumab (360 mg every 3 weeks, administered via IV infusion over at least 30 minutes) for up to 12 months.
A total of 53 subjects will be enrolled in this study, regardless of PD-L1 expression.
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AUC 5, d1 alle drei Wochen
135 mg/m2, d1, 8
Nivolumab 360 mg IV (administered intravenously for more than 30 minutes) every 3 weeks
Including lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
Segmentectomy and wedge resection are not permitted.
Within 6 weeks after definitive surgery, subjects in each cohort who are assessed to have benefited from neoadjuvant therapy (CR, PR, or SD) and have adequately recovered from surgery may receive adjuvant nivolumab (360 mg via IV infusion over at least 30 minutes, every 3 weeks) for up to 12 months, or until disease recurrence or unacceptable toxicity.
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Experimental: Part 3: Real-world cohort
Part 3 aims to evaluate the real-world effectiveness of neoadjuvant chemoimmunotherapy in patients with EGFR/ALK wild-type, potentially resectable or unresectable Stage III NSCLC. Treatment Paradigm: Eligible subjects will receive 3 cycles of neoadjuvant chemoimmunotherapy. Subsequently, a Multidisciplinary Team (MDT) will evaluate and determine the optimal definitive local therapy, triage patients to either radical resection or concurrent chemoradiotherapy (CCRT). Following the completion of local therapy, patients will receive adjuvant or consolidation immunotherapy for a duration of 1 year, administered every 3 weeks (Q3W). Sample Size: The planned enrollment for Part 3 is 215 patients. |
AUC 5, d1 alle drei Wochen
135 mg/m2, d1, 8
Nivolumab 360 mg IV (administered intravenously for more than 30 minutes) every 3 weeks
Including lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
Segmentectomy and wedge resection are not permitted.
Within 6 weeks after definitive surgery, subjects in each cohort who are assessed to have benefited from neoadjuvant therapy (CR, PR, or SD) and have adequately recovered from surgery may receive adjuvant nivolumab (360 mg via IV infusion over at least 30 minutes, every 3 weeks) for up to 12 months, or until disease recurrence or unacceptable toxicity.
In Part 3, for patients who are assessed by a Multidisciplinary Team (MDT) as unable to achieve R0 resection following neoadjuvant chemo-immunotherapy induction, the recommended radiotherapy regimen is: 60 Gy in 30 fractions (5 fractions per week) to 95% of the planning target volume (PTV).
Part 3: For patients who are determined by a Multidisciplinary Team (MDT) to be ineligible for R0 resection following neoadjuvant chemo-immunotherapy induction and require definitive radiotherapy, concurrent chemotherapy will be administered.
The regimen consists of cisplatin 30 mg/m² administered once weekly
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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MPR (Major Pathological Response) rate
Zeitfenster: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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As the primary outcome in part 1. MPR rate, defined as the number of participants with <10% residual tumor in lung and lymph nodes, divided by the number of treated participants for each arm.
Viable tumors in situ carcinoma should not be included in the MPR calculation.
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The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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EFS
Zeitfenster: Since the last patient was enrolled for follow-up for 36 months
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Primary Outcome for Part 2. Outcome Measure Definition: Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events: Disease progression that precludes surgical treatment; Local or distant recurrence; Death from any cause. Progression and recurrence will be assessed by the investigator according to RECIST 1.1. Subjects who die without documented disease progression or recurrence will be considered to have experienced an EFS event on the date of death. |
Since the last patient was enrolled for follow-up for 36 months
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18 months EFS rate
Zeitfenster: The patient was followed up for 18 months after frist cycle neoajuvant treatment.
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Primary Outcome for Part 3. Outcome Measure Definition: 18months Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events: Disease progression that precludes surgical treatment; Local or distant recurrence; Death from any cause. Progression and recurrence will be assessed by the investigator according to RECIST 1.1. Subjects who die without documented disease progression or recurrence will be considered to have experienced an EFS event on the date of death. |
The patient was followed up for 18 months after frist cycle neoajuvant treatment.
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Surgical Conversion Rate
Zeitfenster: Perioperative/Periprocedural
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The primary endpoint of Part 3 is the surgical conversion rate, defined as the proportion of patients who successfully undergo definitive surgery following neoadjuvant chemoimmunotherapy, relative to the total enrolled population (Intent-to-Treat [ITT] analysis set). Statistical Analysis: The surgical conversion rate will be summarized descriptively using frequencies and percentages. The two-sided 95% exact confidence interval (CI) for the proportion will be calculated using the Clopper-Pearson method. |
Perioperative/Periprocedural
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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MPR (Major Pathological response) rate in 2 subgroups patients (PD-L1 <1%, and 1-49%) in Arm B
Zeitfenster: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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In part 1
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The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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Proportion of resection without delay
Zeitfenster: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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In part 1and 2
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The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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Number of Participants with Adverse Events
Zeitfenster: During the treatment period, within at least 100 days after the cessation of neoadjuvant therapy, within 90 days after surgery, and within 30 days after adjuvant therapy.
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In parts 1 and 2 Safety and tolerability will be measured by incidence of AE, SAE, immune related AEs, deaths, and laboratory abnormalities
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During the treatment period, within at least 100 days after the cessation of neoadjuvant therapy, within 90 days after surgery, and within 30 days after adjuvant therapy.
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MRP rate
Zeitfenster: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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Also, as the primary outcome in part 1. MPR rate, defined as number participants with <10% residual tumor in lung and lymph nodes, divided by the number of treated participants for each arm Viable tumors in situ carcinoma should not be included in MPR calculation.
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The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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The EFS rates of all subjects with different PD-L1 expression statuses (PD-L1 < 1%, 1-49% and ≥ 50%)
Zeitfenster: From date of enrollment up to the end of study, 5 years.
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In parts 1 and 2. Outcome Measure Definition: Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events: Disease progression that precludes surgical treatment; Local or distant recurrence; Death from any cause. Progression and recurrence will be assessed by the investigator according to RECIST 1.1. Subjects who die without documented disease progression or recurrence will be considered to have experienced an EFS event on the date of death. |
From date of enrollment up to the end of study, 5 years.
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12 months EFS rate
Zeitfenster: After 12 months of enrollment for all patientsAfter 12 months of enrollment for all patients
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In part 3, the 12-month EFS rate is the proportion of subjects who are alive and event-free at 12 months after the start of treatment.
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After 12 months of enrollment for all patientsAfter 12 months of enrollment for all patients
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OS
Zeitfenster: From the date of enrollment until the date of death, assessed up to 100 months
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In part 3, OS is defined as the time from the start of treatment to death for any reason
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From the date of enrollment until the date of death, assessed up to 100 months
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TDDM (Time to Death or Distant Metastasis)
Zeitfenster: From the date of the first dose of study treatment until the date of first documented distant metastasis or death from any cause, whichever occurs first, assessed up to approximately 60 months.
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In part 3, TDDM is defined as the start of the first treatment to distant metastasis, or death from any cause, whichever occurs first
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From the date of the first dose of study treatment until the date of first documented distant metastasis or death from any cause, whichever occurs first, assessed up to approximately 60 months.
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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pCR rate
Zeitfenster: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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The pCR (complete pathological response) rate is defined as the number of subjects with no residual tumor cells in the lungs and lymph nodes divided by the number of subjects receiving treatment.
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The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks
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OS rate
Zeitfenster: From date of enrollment up to the end of study, 5 years.
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OS is defined as the time since the treatment date and the death date, with the deletion date being the last known date when the subject was still alive
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From date of enrollment up to the end of study, 5 years.
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ORR
Zeitfenster: Within 4 to 6 weeks after the patient completes the neoadjuvant treatment
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ORR is defined as the optimal objective tumor response rate between neoadjuvant therapy and surgery (according to RECIST 1.1 criteria).
All subjects will have their ORR calculated.
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Within 4 to 6 weeks after the patient completes the neoadjuvant treatment
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Safty
Zeitfenster: From the time of enrollment until the completion of adjuvant therapy, which lasted for 13 weeks
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Descriptive statistical analysis of safety data was conducted based on the 4th edition of NCI CTCAE.
According to the most severe level determined by NCI CTCAE V4, all AE/ SAEs that occur after treatment and treatment-related AE/ SAEs will be summarized by systemic organ classification and standard terms.
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From the time of enrollment until the completion of adjuvant therapy, which lasted for 13 weeks
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18m-DFS rate
Zeitfenster: The 18-month DFS rate refers to the probability of being event-free at 18 months calculated from the date of surgery.
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Disease-Free Survival (DFS) is defined as the time from the date of surgery to any of the following events: disease progression, recurrence, or death from any cause.
Disease progression and recurrence will be assessed according to RECIST 1.1 criteria.
For subjects who do not experience a DFS event, the date of censoring will be the date of the last evaluable tumor assessment after surgery.
For subjects who do not experience a DFS event but start subsequent anti-cancer therapy, the date of censoring will be the date of the last evaluable tumor assessment prior to receiving the subsequent anti-cancer therapy.
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The 18-month DFS rate refers to the probability of being event-free at 18 months calculated from the date of surgery.
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Landmark MRD positive rate
Zeitfenster: One month after local therapy
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In part 3, the Landmark MRD positive rate is defined as the proportion of patients who were MRD positive at the Landmark time point among the total study population.
Furthermore, the comparison is made between the proportion of patients with MRD positivity among those who underwent surgery and the proportion of patients with MRD positivity among those who received radiotherapy.
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One month after local therapy
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Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Lungentumoren
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Karzinom, nicht-kleinzellige Lunge
- Aminosäuren, Peptide und Proteine
- Proteine
- Organische Chemikalien
- Therapeutika
- Antikörper, monoklonal, humanisiert
- Antikörper, monoklonal
- Antikörper
- Immunglobuline
- Immunoproteine
- Blutproteine
- Serumglobuline
- Globuline
- Anorganische Chemikalien
- Chlorverbindungen
- Stickstoffverbindungen
- Koordinationskomplexe
- Platinverbindungen
- Nivolumab
- Carboplatin
- Cisplatin
- Arzneimitteltherapie
- 130-nm-Albumin-gebundenes Paclitaxel
Andere Studien-ID-Nummern
- CTONG 1804
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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