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SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Sanhome Pharmaceutical, Co., Ltd.

About this trial

To assess the efficacy and safety of SH-1028 tablets versus placebo in stage II-IIIB non-small cell lung cancer (NSCLC) patients with sensitizing epidermal growth factor receptor (EGFR) mutations, following complete tumor resection, with or without adjuvant chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged at least 18 years, younger than 75 years.

Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.

Before surgery or randomization, MRI or CT scan of the brain and bone scan must be done to exclude metastases.

Complete resection (R0) and systematic lymphadenectomy are mandatory: all surgical margins must be negative for tumor, and there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes.

Disqualifiers

Patients with unresectable or metastatic lesions, residual lesions after surgery, or those who have had only segmentectomies or wedge resection.

Giant mediastinal lymph node metastasis at a single station or mediastinal lymph node fusion into a cluster at multiple stations; lesions invade the heart, aorta, esophagus, or pulmonary veins; Carcinoma of superior lung sulci.

Treatment with any of the following (except for standard platinum -based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy，immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.

Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SH-1028 tablets

    Drug

    The initial dose of SH-1028 tablets is 200 mg once daily.

  • Placebo SH-1028 tablets

    Drug

    Placebo SH-1028 tablets.

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: SH-1028 tabletsExperimental treatment 1 intervention
Group B: Placebo SH-1028 tabletsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease free survival (DFS) assessed by Independent Review Committee (IRC)

Disease-free survival is defined as the time from randomization until the date of the recurrence of tumor or death. The primary endpoint of DFS was based on the assessment of IRC.

Time frame
From the time of randomization to the recurrence of tumor or death, through study completion, an average of 5 years

Secondary outcomes

1

Disease free survival (DFS) assessed by investigators

The secondary endpoint of DFS was based on the assessment of investigators.

Time frame
From the time of randomization to the recurrence of tumor or death, through study completion, an average of 5 years
2

DFS rate at 2, 3 and 5 years assessed by IRC

DFS rate at 2, 3 and 5 years is defined as the proportion of patients alive and disease free at 2, 3 and 5 years, respectively.

Time frame
From the time of randomization to the recurrence of tumor or death, up to 5 years
3

Overall survival (OS)

Overall survival is defined as the time from the date of randomization until death from any cause.

Time frame
From the time of randomization to death, through study completion, an average of 5 years
4

OS rate at 5 years

OS rate at 5 years is defined as the proportion of patients alive at 5 years.

Time frame
From the time of randomization to death, up to 5 years

Other outcomes

Sponsors and contacts

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

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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