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Non-Squamous Non-Small Cell Lung CancerPhase 3NCT01328951

A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy

A Phase 3 study testing Erlotinib and Second-Line Chemotherapy in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 155 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
Erlotinib and Second-Line Chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
643 participants
Where
155 sitesin 20 countries
Study dates
Sep 2011to Jan 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
  • Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
  • Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to [≤] 28 days prior to randomization)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Who cannot join

  • Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
  • Participants whose tumors harbor an EGFR-activating mutation
  • Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
  • Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
  • Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
  • Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
Show all 9Show fewer
  • Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
  • Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
  • Any inflammatory changes of the surface of the eye

Trial locations and contacts

155 sites in 20 countries.

155 sites in 20 countries

China15 sites

  • Study site

    Beijing, 100142

  • Study site

    Beijing, 100730

  • Study site

    Changchun, 130012

  • Study site

    Fuzhou, 350014

  • Study site

    Guangzhou, 510515

  • Study site

    Guangzhou

  • Study site

    Harbin, 150081

  • Study site

    Shanghai, 200030

  • Study site

    Shanghai, 200433

  • Study site

    Shantou, 515041

  • Study site

    Shenyang, 110001

  • Study site

    Suzhou, 215004

  • Study site

    Tianjin, 300060

  • Study site

    Wuhan, 430071

  • Study site

    Xi'an, 710061

Other trials in China

Hungary14 sites

  • Study site

    Budapest, 1121

  • Study site

    Budapest, 1122

  • Study site

    Budapest, 1125

  • Study site

    Budapest, 1145

  • Study site

    Deszk, 6772

  • Study site

    Farkasgyepű, 8582

  • Study site

    Győr, 9024

  • Study site

    Gyula, 5703

  • Study site

    Mátraháza, 3233

  • Study site

    Miskolc, 3526

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szolnok, 5000

  • Study site

    Törökbálint, 2045

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Italy12 sites

  • Study site

    Avellino, Campania, 83100

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Legnago, Lombardy, 37045

  • Study site

    Livorno, Tuscany, 57124

  • Study site

    Parma, Emilia-Romagna, 43100

  • Study site

    Pisa, Tuscany, 56100

  • Study site

    Rome, Lazio, 00144

  • Study site

    Rome, Lazio, 00151

  • Study site

    Rome, Lazio, 00168

  • Study site

    S. Giovanni Rotondo, Apulia, 71013

  • Study site

    Treviglio, Lombardy, 24047

  • Study site

    Verona, Veneto, 37134

Other trials in Italy

Romania12 sites

  • Study site

    Baia Mare, 430031

  • Study site

    Brăila, 810325

  • Study site

    Brasov, 500091

  • Study site

    Brasov, 500152

  • Study site

    Bucharest, 010976

  • Study site

    Bucharest, 022328

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Cluj-Napoca, 400058

  • Study site

    Cluj-Napoca, 400132

  • Study site

    Oradea, 410167

  • Study site

    Ploieşti, 100337

  • Study site

    Târgu Mureş, 540136

Other trials in Romania

Ukraine12 sites

  • Study site

    Dnipropetrovsk, 49102

  • Study site

    Donetsk, 83092

  • Study site

    Kharkiv, 61024

  • Study site

    Kirovograd, 25011

  • Study site

    Kyiv, 03022

  • Study site

    Kyiv, 03115

  • Study site

    Kyiv, 04107

  • Study site

    Lutsk, 63000

  • Study site

    Sumy, 40005

  • Study site

    Uzhhorod, 88000

  • Study site

    Vinnytsia, 21029

  • Study site

    Zaporizhzhya, 69040

Other trials in Ukraine

Bulgaria11 sites

  • Study site

    Gabrovo, 5300

  • Study site

    Haskovo, 6300

  • Study site

    Plovdiv, 4004

  • Study site

    Rousse, 7000

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1303

  • Study site

    Sofia, 1527

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1756

  • Study site

    Sofia, 1784

  • Study site

    Varna, 9010

Other trials in Bulgaria

United States9 sites

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Dayton, Ohio, 45420

  • Study site

    Gilroy, California, 95020

  • Study site

    Kansas City, Missouri, 64132

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Missoula, Montana, 59802

  • Study site

    Spokane, Washington, 99218

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Washington D.C., District of Columbia, 20010

Other trials in United States

Brazil9 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-281

  • Study site

    Florianópolis, Santa Catarina, 88034-000

  • Study site

    Ijuí, Rondônia, 98700-000

  • Study site

    Lajeado, Rio Grande do Sul, 95900-000

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90470340

  • Study site

    Santo André, São Paulo, 09060-650

Other trials in Brazil

France8 sites

  • Study site

    Bayonne, 64109

  • Study site

    Compiègne, 60321

  • Study site

    Gap, 05007

  • Study site

    Libourne, 33505

  • Study site

    Lille, 59020

  • Study site

    Nantes, 44202

  • Study site

    Saint-Brieuc, 22027

  • Study site

    Villefranche-sur-Saône, 69655

Other trials in France

Czechia7 sites

  • Study site

    České Budějovice, 370 87

  • Study site

    Jindřichův Hradec, 377 01

  • Study site

    Nymburk, 288 01

  • Study site

    Ostrava - Poruba, 708 52

  • Study site

    Prague, 150 06

  • Study site

    Prague, 180 81

  • Study site

    Tábor, 390 03

Other trials in Czechia

Taiwan7 sites

  • Study site

    Kaohsiung City, 00833

  • Study site

    Taichung, 40447

  • Study site

    Taichung, 40705

  • Study site

    Taipei, 00112

  • Study site

    Taipei, 100

  • Study site

    Taipei, 112

  • Study site

    Taipei, 11490

Other trials in Taiwan

Slovakia6 sites

  • Study site

    Banská Bystrica, 975 17

  • Study site

    Bardejov, 085 01

  • Study site

    Košice, 04001

  • Study site

    Nové Zámky, 940 02

  • Study site

    Poprad, 058 01

  • Study site

    Rimavská Sobota, 97901

Other trials in Slovakia

Netherlands5 sites

  • Study site

    Arnhem, 6800 TA

  • Study site

    Heerlen, 6419 PC

  • Study site

    Hoorn, 1625 HV

  • Study site

    Sittard-Geleen, 6162 BG

  • Study site

    Zutphen, 7207 AE

Other trials in Netherlands

Poland5 sites

  • Study site

    Brzozów, 36-200

  • Study site

    Krakow, 31-115

  • Study site

    Poznan, 60-569

  • Study site

    Wodzisław Śląski, 44-300

  • Study site

    Zamość, 22-400

Other trials in Poland

South Africa5 sites

  • Study site

    Cape Town, 7570

  • Study site

    Cape Town, 7700

  • Study site

    George, 6530

  • Study site

    Port Elizabeth, 6045

  • Study site

    Pretoria, 0002

Other trials in South Africa

South Korea5 sites

  • Study site

    Gyeonggi-do, 463-707

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 150-713

  • Study site

    Suwon, 442-723

Other trials in South Korea

Canada4 sites

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Québec, Quebec, G1V 4G5

  • Study site

    Regina, Saskatchewan, S4T 7T1

  • Study site

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Thailand4 sites

  • Study site

    Bangkok, 10700

  • Study site

    Hat Yai, 90110

  • Study site

    Muang, 50200

  • Study site

    Muang, 57000

Other trials in Thailand

Latvia3 sites

  • Study site

    Daugavpils, 5417

  • Study site

    Riga, LV-1079

  • Study site

    Riga, LV1002

Other trials in Latvia

Lithuania2 sites

  • Study site

    Kaunas, 50009

  • Study site

    Vilnius, 08660

Other trials in Lithuania

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-Based Chemotherapy

This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.

Being tested
Placebo, Erlotinib, Second-Line Chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.

  • Second-Line ChemotherapyDrug

    Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.

Study groups in NCT01328951
Study groupRoleWhat they receive
Early ErlotinibExperimentalParticipants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Receives: Drug: Erlotinib; Drug: Second-Line Chemotherapy
Late ErlotinibPlacebo comparatorParticipants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Receives: Drug: Placebo; Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Died During the Overall Study

    Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.

    Measured: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)

  2. Overall Survival (OS) as Median Time to Event During the Overall Study

    Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.

    Measured: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)

  3. Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study

    Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.

    Measured: At 1 year

Secondary outcomes (6)

  1. Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment

    Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.

    Measured: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)

  2. Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment

    Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.

    Measured: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)

  3. Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment

    Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.

    Measured: At 6 months

  4. Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment

    Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.

    Measured: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)

  5. Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment

    Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.

    Measured: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)

  6. Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment

    Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.

    Measured: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328951
Sponsor's protocol ID
BO25460
Status last verified
Jun 2016
First submitted
4 Apr 2011
Last updated
28 Oct 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib and Second-Line Chemotherapy in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 155 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in China, Hungary, Italy, Romania, Ukraine and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Died During the Overall Study (time frame: Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01328951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.

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