Randomized, Comparative Phase III Study of Docetaxel Monotherapy, Versus Carboplatin + Pemetrexed Followed by Pemetrexed Maintenance Therapy, for Advanced Non-Squamous Non-Small-Cell Lung Cancer in Elderly Patients

The standard treatment for patients over 75 years old with advanced non-small-cell lung cancer is single-agent docetaxel chemotherapy, but this treatment does not yet have satisfactory efficacy; better treatment methods must be developed.

For patients under 75 with advanced non-small-cell lung cancer, the standard therapy is to administer carboplatin or cisplatin, in combination with other anti-cancer agents.

Carboplatin and cisplatin are anti-cancer drugs with similar effects; of the two, carboplatin is more widely used, due to the lesser severity of side effects such as nausea. For that reason, we wondered whether combination therapy using carboplatin could be used for elderly patients, for greater efficacy. However, though therapy combining carboplatin and pemetrexed is anticipated to be highly efficacious, it remains unclear which option is truly superior, as we have not yet examined the advantages and disadvantages of this therapy, such as burden on the body and side effects, compared to the current docetaxel monotherapy.

This clinical trial was therefore designed to compare these two therapy options, particularly for patients 75 and older, and to determine whether the combination of carboplatin + pemetrexed is superior to the standard docetaxel monotherapy.

Randomized Phase III Study of TS-1 Maintenance Therapy after CBDCA + TS-1 Combination Therapy for Chemotherapy-Naive Stage IIIB/IV Squamous Cell Lung Cancer

For initial chemotherapy of advanced squamous cell lung cancer, based on the results of studies on non-small-cell lung cancer, various combination chemotherapies (PlatinumDoublet) using a combination of third-generation anti-cancer agents known as platinum-based drugs, such as cisplatin and carboplatin, are currently recommended as the standard treatment in the Japan Lung Cancer Society’s Guidelines for Diagnosis and Treatment of the Lung Cancer 2010, and these combination chemotherapies are widely used in everyday clinical practice.

However, the effect on survival period remains inadequate, and advances in chemotherapy and the development of new therapy strategies are essential to further improve therapeutic outcomes. This clinical trial was therefore designed to evaluate the efficacy and safety of maintenance therapy with TS-1, compared to the follow-up observation group, in patients with advanced squamous cell lung cancer who responded to the combination of carboplatin and TS-1 as an initial therapy, and to verify whether maintenance therapy with TS-1 is an effective therapeutic strategy in the treatment of advanced squamous cell lung cancer.

Phase III Study of Combined Pemetrexed + Bevacizumab Therapy, Compared with Bevacizumab Monotherapy, as Maintenance Therapy after Administration of Combined Carboplatin + Pemetrexed + Bevacizumab Therapy for Non-Squamous Non-Small-Cell Lung Cancer with Negative or Unknown Epidermal Growth Factor Receptor Gene Mutation

When there are additional therapies scheduled after the first therapy (primary therapy) performed for a person diagnosed with advanced lung cancer, the first such therapy is called “induction therapy,” and therapy performed following the induction therapy is called “maintenance therapy.”

Maintenance therapy mainly uses drugs with less significant side effects, with the goal of maintaining the effects achieved through induction therapy. The purpose of this clinical trial is to establish a better treatment method, by comparing and analyzing whether bevacizumab alone, or bevacizumab + pemetrexed, is superior as a maintenance therapy after what is considered the standard induction therapy for non-squamous cell lung cancer: four courses of carboplatin + pemetrexed chemotherapy in combination with bevacizumab.

The results should elucidate which maintenance therapy will be more beneficial to patients.