Know Cancer

forgot password

A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)

Open randomized multicenter phase II study in patiƫnts in need of 2nd line treatment for
advanced/metastatic NSCLC. Efficacy and safety of monotherapy with erlotinib will be
compared with combination therapy of erlotinib and chemotherapy. In recent studies it was
established that pemetrexed activity is more pronounced in non-squamous NSCLC in comparison
to squamous cell carcinoma. Therefore in patients with non-squamous carcinoma pemetrexed
will be used. As in second line treatment of NSCLC docetaxel is registered also for usage in
patients with squamous cell carcinoma, docetaxel will be used in patients with squamous

Chemotherapy will be limited to 4 courses. Erlotinib will be continued until disease
progression or unacceptable toxicity.

Erlotinib as monotherapy will be administered continuously. In combination with
chemotherapy, erlotinib will be given from day 2-16 of every course of 3 weeks.

Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC, locally advanced and metastatic
disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic
treatment regimens which should have included a platinum agent.

2. Complete recovery from prior chemotherapy side effects to < Grade 2.

3. At least one unidimensional measurable lesion meeting RECIST criteria.

4. ECOG PS 0-2.

5. Age > 18 years.

6. Adequate organ function, including:

- Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.

- Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 1.5 x ULN AP, ALT, and AST <5 x
ULN is acceptable if the liver has tumor involvement

- Renal: calculated creatinin clearance > 40 ml/min based on the Cockcroft-Gault

7. Estimated life expectancy >12 weeks.

8. Male and female patients with reproductive potential must use an approved
contraceptive method, if appropriate. Female patients with childbearing potential
must have a negative serum pregnancy test within 7 days prior to study enrollment.

9. Signed informed consent.

10. Patient compliance and geographical proximity that allow adequate follow up.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Patients with medical risks because of non-malignant disease as well as those with
active uncontrolled infection.

3. Documented brain metastases unless the patient has completed local therapy for
central nervous system metastases and has been off corticosteroids for at least two
weeks before enrollment.

4. Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment
with pemetrexed and in squamous earlier treatment with docetaxel.

5. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a
5-day period (5 day period for long-acting agents such as piroxicam).

6. Inability or unwillingness to take folic acid, vitamin B-12 supplementation or

7. Concomitant treatment with any other experimental drug under investigation.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Chest X ray, CT. Bone scan, brain scan (if clinically indicated) for Progression free survival Response rate Duration of response

Outcome Time Frame:

Every 6 weeks until disease progression

Safety Issue:


Principal Investigator

Joachim G. Aerts, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

Amphia Ziekenhuis, Breda, The Netherlands


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

March 2009

Completion Date:

June 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung cancer
  • non-small-cell
  • erlotinib
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms