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Lung cancer combo shows promise in Second-Line trial

NCT ID NCT01350817

Disease control Sponsor: University Hospital, Limoges Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This phase 2 study tested whether adding the targeted drug erlotinib to standard chemotherapy (docetaxel) works better than chemotherapy alone for people with advanced non-small cell lung cancer whose first treatment stopped working. 156 participants were randomly assigned to one of two groups. The main goal was to see how long the cancer stayed under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
erlotinib and docetaxel
What this could lead to
If successful, this combination could offer a new second-line treatment option for people with advanced non-small cell lung cancer, potentially delaying disease progression.
What could go wrong
This is a phase 2 trial with a modest sample size, so results may not be definitive. The combination may not improve survival and could increase side effects like rash or fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

156 people

The number who actually took part.

Start date

Jun 2011

Finished

Jan 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically proven NSCLC ( * Mutational status of EGFR : wild type or unknown * Stage IV disease with cytologic or histologic documentation in patients with a single easily accessible metastasis or metastatic relapses in a non irradiated region from a primary tumor treated with surgery or radiotherapy (with cytologic or histologic documentation of relapse) * Presence of at least one measurable target lesion (one dimension) in a non irradiated region (at least 10 mm on spiral computed tomography). * Age ≥ 18 years * Performance status 0,1,2 exception : age \> 74 years only PS 0 or 1 * Normal hepatic function * Normal renal function * Normal calcemia * Normal haematological function * Life expectancy \> 12 weeks. * Women of child bearing potential must use effective contraception. * Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment. * Written informed consent to participate in the study. Exclusion Criteria: * PS \> 2, exception : age \> 74 years only PS ≥ 2 * Presence of another cancer * Previous treatment with an anti egfr agent or docetaxel * QT prolongation (\>470 ms) * Uncontrolled arterial hypertension. * Concurrent radiotherapy, except for palliative bone irradiation. * Stroke less than 6 months before study entry. * Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial * Uncontrolled infection. * Caval syndrome * Other organic disorders preventing inclusion in the trial * Malabsorption syndrome * Allergy to erlotinib or one of its constituents * Allergy to docetaxel or one of its constituents * Pregnancy and breast-feeding * Surgery less than two months before study entry

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • CH de Meaux

    Meaux, France

  • CHU Brest

    Brest, France

  • CHU Reims

    Reims, France

  • Clinique Pneumologique; Hôpital Charles Nicolle

    Rouen, 76031, France

  • Département de Pathologie Respiratoire du CHU de Limoges

    Limoges, France

  • Département des Maladies Respiratoires ; Hôpital Sainte Marguerite

    Marseille, 13274, France

  • Hôpital Charles Nicolle, Service de Pneumologie

    Rouen, France

  • Service de Pneumologie

    Beauvais, France

  • Service de Pneumologie

    Bordeaux, France

  • Service de Pneumologie

    Charleville Mezière, France

  • Service de Pneumologie

    Créteil, France

  • Service de Pneumologie

    Draguignan, France

  • Service de Pneumologie

    Elbeuf, France

  • Service de Pneumologie

    Gap, France

  • Service de Pneumologie

    Meaux, France

  • Service de Pneumologie

    Mulhouse, France

  • Service de Pneumologie

    Villefranche, France

  • Service de Pneumologie - Hôpital St Antoine, Paris

    Paris, 75571, France

  • Service de Pneumologie ; Centre hospitalier

    Charleville-Mézières, 08 000, France

  • Service de Pneumologie, CHU Angers

    Angers, 49033, France

  • Service de Pneumologie, Hôpital Nord

    Saint-Etienne, France

  • Service de Pneumologie, Hôpital Pontchailloux

    Rennes, France

  • Service de Pneumologie, Hôpital de la Croix Rousse

    Lyon, France

  • Service de Pneumologie-Allergologie; Centre Hospitalier Général

    Périgueux, 24019, France

  • Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay

    Mantes-la-Jolie, 78200, France

  • Service de Pneumologie; CHG de Roanne

    Roanne, 42300, France

  • Service de Pneumologie; Centre Hospitalier

    Beauvais, 60 021, France

  • Service de Pneumologie; Centre Hospitalier

    Draguignan, 83300, France

  • Service de Pneumologie; Hôpital Bois Guillaume

    Rouen, 76233, France

  • Service de pneumologie; Centre Hospitalier d'Annecy

    Annecy, 74011, France

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