A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer (CCODG-NSCLC)

  • End date
    Dec 11, 2025
  • participants needed
  • sponsor
    Shanghai Jiao Tong University School of Medicine
Updated on 11 May 2022
lung cancer
cancer chemotherapy


The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.


Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.

In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Condition Recurrent Non-small Cell Lung Cancer
Treatment cisplatin, docetaxel, carboplatin, Placebo, Gemcitabine/Carboplatin, Gemcitabine/Cisplatin, Docetaxel/Oxaliplatin, Docetaxel/Carboplatin
Clinical Study IdentifierNCT02889666
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on11 May 2022


Yes No Not Sure

Inclusion Criteria

Age ≤ 75 years with histologically proven NSCLC
No severe major organ dysfunction
WHO performance status of 0 or 1
No prior cancer chemotherapy
A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan

Exclusion Criteria

Age ≥ 76
Severe major organ dysfunction
WHO performance status of >1
Prior cancer chemotherapy
Stage IV
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