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IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer

ConditionResectable Stage II-III Non-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

This is a Phase 2 study to evaluate the safety, and efficacy of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and Females, age ≥18 years and ≤75 years;

Stage II, IIIA or IIIB (N2) NSCLC (per AJCC8);

No administration of any anti-NSCLC therapy in the pre-operative period;

Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.

Disqualifiers

Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;

Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;

Pancoast tumor;

Malignant tumor nodule in the contralateral lung lobe;

Trial design

Design model

Single group

Treatments tested in this trial

  • IBI363

    Drug

    Subjects will receive IBI363 for up to 4 cycles, each cycle is 21 days, the first treatment cycle is 28 days

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Neoadjuvant TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathologic Complete Response (pCR) rate

pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy

Time frame
Up to approximately 8 weeks following completion of neoadjuvant treatment
2

Safety parameters: the incidence of Treatment-related Adverse Event, (TRAEs)

Time frame
up to 90 days after the last dose
3

Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)

Time frame
up to 90 days after the last dose
4

Safety parameters: the incidence of immune-related adverse events (irAEs)

Time frame
up to 90 days after the last dose

Secondary outcomes

1

Event Free Survival (EFS)

EFS is defined as the time from the first dose to the first determination by the investigator with RECIST v1.1 of inoperable disease progression, postoperative local recurrence or distant metastasis, development of another primary tumor, or death from any cause, whichever occurred first.

Time frame
Up to approximately 5 years
2

Major Pathological Response (mPR) Rate

mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

Time frame
Up to approximately 8 weeks following completion of neoadjuvant treatment
3

Objective Response Rate （ORR）Rate

ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria.

Time frame
Up to approximately 5 years
4

Disease Control Rate (DCR) Rate

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: