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Platinum-based Chemotherapy

Chemotherapy + Erlotinib for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By Tina Cascone, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-treatment

Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they are effective in treating non-small cell lung cancer.

Who is the study for?

This trial is for patients with stage I-III non-small cell lung cancer who've had surgery. They must have normal kidney and liver function, no prior chemotherapy or radiation, be able to handle chemo before more surgery, not be pregnant or breastfeeding, agree to use contraception, and have no severe infections or illnesses that could interfere with the study.Check my eligibility

What is being tested?

The trial tests a combination of chemotherapy drugs (docetaxel and cisplatin) with erlotinib hydrochloride on patients post-surgery. The goal is to see if this mix can better stop tumor growth by killing cells directly or blocking enzymes tumors need to grow.See study design

What are the potential side effects?

Possible side effects include reactions from the infusion of drugs like fatigue and nausea; damage to organs such as kidneys and liver due to toxicity; nerve pain from neuropathy; allergic reactions; increased risk of infection; blood disorders like low white cell count.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer can be removed with surgery and I haven't had chemotherapy or radiation before.

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My kidney function is normal or nearly normal.

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My lung cancer is confirmed and is at stage I, II, or III.

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I am currently not suffering from any sudden illnesses or infections.

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I can undergo chemotherapy before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue

Rate of grade 3 or greater toxicities (hematologic or non-hematologic)

Secondary outcome measures

Evaluation of immune-based biomarkers

Incidence of EGFR mutations

Time to progression

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (docetaxel, cisplatin, erlotinib hydrochloride)Experimental Treatment5 Interventions

Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning within 90 days following definitive surgical resection, patients receive erlotinib hydrochloride PO daily for up to 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Erlotinib Hydrochloride

2010

Completed Phase 2

~2850