ClinicalTrials.gg
TerminatedNCT03496766Updated Mar 5, 2025Results posted

Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS

A Phase 2 interventional study of Tipifarnib in Non Small Cell Lung Cancer, sponsored by Spanish Lung Cancer Group. Terminated at 30 sites in Spain. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Spanish Lung Cancer Group · Phase 2, Interventional, and Treatment

Why this study was terminated
The recruitment was closed prematurely to due to slow recruitment.

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Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 17 studies in Carcinoma, Non-Small-Cell Lung by Spanish Lung Cancer Group — none open to participants now, none under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Spanish Lung Cancer Group.

Enrollment
13th of 13
9 · median 140
Started
2018
with 2 others
Phase 2
6 of 17
none open now
Registered
16th of 17
by date

Among the 17 studies in Carcinoma, Non-Small-Cell Lung by Spanish Lung Cancer Group, this one is the 13th largest by enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2018, is one of 6 in phase 2, and was the 16th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

None of the 17 studies in Carcinoma, Non-Small-Cell Lung by Spanish Lung Cancer Group is open now. The open studies under Carcinoma, Non-Small-Cell Lung, anywhere →

Where they have run

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 17 studies in Carcinoma, Non-Small-Cell Lung by Spanish Lung Cancer Group as a file.
02

Study summary

This Phase II study consists of 2 parts: 1) pre-screening phase and 2) treatment phase.

The pre-screening phase will investigate the presence of HRAS mutations in subjects with a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC). Subjects may participate in the pre-screening phase at initial diagnosis or following prior lines of therapy for SQ-NSCLC.

The treatment phase will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations and for whom there is no curative therapy available.

Read the detailed description

Subject enrolment may proceed with information available on tumor HRAS status previously generated during the pre-screening phase, but all subjects must consent to provide tumor slides (or tumor tissue block) from a prior diagnostic biopsy for a retrospective testing of RAS gene status, including T81C polymorphism, and other potential biomarkers at a central facility.

Tipifarnib will be administered at a starting dose of 600 mg, po, bid daily on days 1-7 and 15-21 of 28-day treatment cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment for up to 24 months in the absence of disease progression and unmanageable toxicity. Treatment may continue beyond 24 months if there is documented evidence of continued clinical benefit.

Tumor assessments will be performed at screening and approximately every 8 weeks for the first 6 months (cycles 2, 4, 6) and then every 12 weeks (cycles 9, 12, 15, etc.) until disease progression, starting at the end of Cycle 2. Additional tumor assessments may be conducted if deemed necessary by the Investigator or for a confirmation of an objective response. Subjects who discontinue tipifarnib treatment for reasons other than disease progression must continue tumor assessments until disease progression, withdrawal of subject's consent to study procedures or initiation of another anticancer therapy.

Determination of objective tumor response will be performed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Electronic copies of tumor images may be de-identified of subject's personal information at the clinical sites and collected by the Sponsor to undergo an external independent radiological review if the sponsor deems it necessary for the final assessment of treatment efficacy. Subjects with a solitary site of disease who have experienced a response may be considered for surgical resection. Subjects with a best response of a partial response and residual disease after salvage surgery will be eligible to continue on study therapy. Information on the duration of response to the last prior therapy will be collected.

Upon disease progression, subjects will be followed approximately every 12 weeks for survival until either death or 24 months after accrual in the subject's study cohort has been completed, whichever occurs first. Information on subsequent anticancer therapy will be collected.

All subjects will be followed-up for safety during treatment and for approximately 30 additional days after treatment discontinuation (or until immediately before the administration of another anticancer treatment). Additional safety follow up may be conducted if unresolved toxicity is present at the End of Treatment visit.

03

Conditions studied

  • Non Small Cell Lung Cancer
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject has a or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC) for which there is no curative therapy available.
  2. Subject has (progressive disease) or is refractory to one or more prior therapies. In the case of therapy received in the or neo-adjuvant setting, relapse must have occurred within 12 months to be considered prior therapy. Subject may have received prior immunotherapy.
  3. Subject has a tumor that carries a missense HRAS mutation. HRAS status may have been assessed either in blood, primary tumor tissue, recurrent or disease.
  4. Subject has consented to provide tumor slides (or tumor tissue blocks) for biomarker evaluation. Before enrolment the site must confirm the availability of the tumor sample. If there is no sample available, the trial chair must be contacted for approval. If enrolment in the treatment portion of the study has taken place based on HRAS mutant status as assessed using a blood sample, tumor tissue must be sent before starting cycle 2 of treatment, and It will be used in part for confirmation of HRAS mutant tumor status. Confirmation of HRAS mutant status in tumor tissue is required for continuation of treatment. If HRAS mutation is not confirmed in tumor but is clearly positive in blood, the trial chair will be contacted for approval and the treatment could be maintained. All treated subjects will be evaluated for safety.
  1. At least 2 weeks since the last systemic therapy regimen prior to enrolment. Subjects must have recovered to v. 4.03 \< Grade 2 from all acute toxicities (excluding Grade 2 toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
  1. At least 2 weeks since last radiotherapy. If radiation was localized to the only site of , there must be documentation of disease progression of the irradiated site. Subjects must have recovered from all acute toxicities from radiotherapy. Subjects may be on a daily dose of (≤ 20mg prednisone or equivalent), as part of their management from prior radiotherapy.
  1. (Eastern cooperative oncology group) performance status of 0 or 1. 9. Acceptable liver function:
  1. less than 1.5 times (x ULN); does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
  2. Aspartate Amino-transferasa (SGOT) and ALT Aspartate-Alanina-transferase (SGPT) less than 3 x ULN; if liver metastases are present, then ≥ 5 x ULN is allowed.

    1. Acceptable renal function with serum creatinine less than 1.5 x ULN or a calculated ≥ 60 mL/min using the Cockcroft-Gault formula.
    1. Acceptable hematologic status:

a. (absolut neuthophil count) ≥ 1000 cells/μL. b. count ≥ 75,000/μL. c. ≥ 9.0 g/dL. 12. Female subjects must be either:

  1. Of non- (surgically sterilized or at least 2 years ); or
  2. If of child-bearing potential, subject must use an adequate method of consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication.
  3. Not breast feeding at any time during the study. 13. Written and voluntary for the treatment phase understood, signed and dated.

Exclusion criteria

Exclusion Criteria:

  1. Ongoing treatment with an anticancer agent not contemplated in this protocol.
  2. Prior treatment (at least 1 full treatment cycle) with an FTase inhibitor.
  3. Any history of coronary artery disease or myocardial infarction within the last 3 years, (NYHA) grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
  4. Known uncontrolled brain, or epidural (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1).
  5. Non-tolerable > Grade 2 neuropathy or evidence of emerging or rapidly progressing neurological symptoms within 4 weeks of Cycle 1 Day 1. Non-tolerable grade 2 toxicities are defined as those with moderate symptoms that the patient is not able to endure for the conduct of instrumental activities of daily life or that persists ≥ 7 days.
  6. Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
  7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with , or an active infection with or .
  8. Subjects who have exhibited allergic reactions to tipifarnib or structural compounds similar to tipifarnib or to the drug product . This includes to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class. Patients with hypersensitivity to these agents will be excluded from enrolment.
  9. Required use of concomitant medications classified as strong inhibitors or inducers of cytochrome P450 3A4 () or UDP-glucuronosyltransferase (UGT)
  10. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
  11. The subject has legal incapacity or limited legal capacity.
  12. Significantly altered mental status that would limit the understanding or rendering of and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.
Terms in these criteria, in plain language(28)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Experimental Arm

    Tipifarnib 600 mg, po, bid daily on days 1-7 and 15-21 of 28-day treatment cycles for up to 24 months

    Drug: Tipifarnib

Interventions

  • Tipifarnib 600 mg will be administered until progression

    Also known as: Zarnestra

06

What researchers measure

Primary outcomes

  1. Overall Response

    To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions.

    Time frame: From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the first dose

Secondary outcomes

  1. Progression Free Survival

    Defined as the time from the start date of treatment TMT as the origin of follow-up and the first progression or death as final date.

    Time frame: From the start of treatment until first progression or death.

  2. Overall Survival

    Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

    Time frame: From the date of randomization until end of follow up,up to 24 months

07

Results

Posted Mar 29, 2024
Limitations and caveats
The recruitment was closed prematurely to due to slow recruitment, so there are no consistent data to achieve any relevant conclusion at this point.

Participant flow

Participant flow — Overall Study
MilestoneExperimental Arm
Started9
Completed9
Not completed0

Outcome measures

PrimaryOverall Response

To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions.

Time frame:
From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the first dose
Reported as:
Count of participants · Participants
Overall Response
ParticipantsExperimental Arm
Stable Disease2
Progression Disease4
SecondaryProgression Free Survival

Defined as the time from the start date of treatment TMT as the origin of follow-up and the first progression or death as final date.

Time frame:
From the start of treatment until first progression or death.
Reported as:
Median · months
Progression Free Survival
monthsExperimental Arm
Progression Free Survival8.6 ± 18.7
SecondaryOverall Survival

Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

Time frame:
From the date of randomization until end of follow up,up to 24 months
Reported as:
Median · Months
Overall Survival
MonthsExperimental Arm
Overall Survival12.4 (9.7 to 21.7)

Adverse events

Collected over 25 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Arm9/9 (100%)9/9 (100%)9/9 (100%)
Most frequent serious events
Most frequent serious events
EventExperimental Arm
Renal and urinary disordersRenal and urinary disorders6/9
DyspneaRespiratory, thoracic and mediastinal disorders2/9
Platelet count decreasedBlood and lymphatic system disorders2/9
Acute kidney injuryRenal and urinary disorders1/9
FatigueGeneral disorders1/9
Nervous system disordersNervous system disorders1/9
Thromboembolic eventBlood and lymphatic system disorders1/9
SepsisInfections and infestations1/9
Most frequent other events
Most frequent other events
EventExperimental Arm
AnemiaBlood and lymphatic system disorders9/9
HyperglycemiaInvestigations7/9
ConfusionGeneral disorders1/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)Experimental Arm
Mean68.8 ± 5.4
Sex: Female, Male
Sex: Female, Male(Participants)Experimental Arm
Female1
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental Arm
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White9
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Experimental Arm
Spain9
Cigarette Smoking History
Cigarette Smoking History(Participants)Experimental Arm
Never smoker (<= 100 cigarettes/lifetime)0
Former smoker (>= 1 year)5
Active smoker4
ECOG Performance status
ECOG Performance status(Participants)Experimental Arm
ECOG 00
ECOG 19
ECOG 20
ECOG 30
ECOG 40
Pulse rate
Pulse rate(bpm)Experimental Arm
Mean88.8 ± 12.1
Systolic Blood Pressure
Systolic Blood Pressure(mmHg)Experimental Arm
Mean121.8 ± 22.2

8 further baseline measures are reported on the registry.

08

Study locations

30 sites
  • Complejo Hospitalario Universitario de Santiago
    Santiago De Compostela, A Coruña 15706, Spain
  • Hospital Virgen de los Lirios
    Alcoy, Alicante 03804, Spain
  • Hospital General Universitario de Elche
    Elche, Alicante 03203, Spain
  • Hospital Central de Asturias
    Oviedo, Asturias, Spain
  • ICO-Badalona
    Badalona, Barcelona 08916, Spain
  • ICO-Hospitalet
    L'Hospitalet de Llobregat, Barcelona 08908, Spain
  • Hospital Provincial de Castellón
    Castelló de la Plana, Castelló 12002, Spain
  • Hospital Universitario Fundación Alcorcón
    Alcorcón, Madrid 28922, Spain
  • Hospital Universitario de la Arrixaca
    El Palmar, Murcia 30120, Spain
  • Hospital Costa del Sol
    Marbella, Málaga 29603, Spain
  • Complejo Hospitalario de Navarra
    Pamplona, Navarra 31008, Spain
  • Hospital Sant Joan de Reus
    Reus, Tarragona 43204, Spain
  • H. Universitario de Canarias
    La Laguna, Tenerife 38320, Spain
  • H.U.Vall D´Hebrón
    Barcelona, 08035, Spain
  • H. Clinic i Provincial
    Barcelona, 08036, Spain
  • Hospital de La Santa Creu I Sant Pau
    Barcelona, 08041, Spain
  • Hospital Universitario de Ciudad Real
    Ciudad Real, 13005, Spain
  • ICO Girona -H. Dr. Josep Trueta
    Girona, 17007, Spain
  • Hospital de Jaén
    Jaén, 23007, Spain
  • Hospital Lucus Agustí
    Lugo, 27003, Spain
  • Hospital La Princesa
    Madrid, 28006, Spain
  • Hospital Puerta de Hierro
    Madrid, 28222, Spain
  • H. 12 de Octubre
    Madrid, Spain
  • H. Carlos Haya
    Málaga, 29010, Spain
  • H. Son Llàtzer
    Palma de Mallorca, 07198, Spain
  • Hospital Clinico de Salamanca
    Salamanca, 37007, Spain
  • Hospital Virgen de La Macrena
    Sevilla, 41009, Spain
  • Hospital Clínico Universitario de Valencia
    Valencia, 46010, Spain
  • H. General U. de Valencia
    Valencia, 46014, Spain
  • Hospital La Fe
    Valencia, Spain
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Oct 2022, 53 months.

Results were first posted in Mar 2024, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2018
First posted
Apr 12, 2018
StartActual
May 7, 2018
Primary completionActual
Oct 30, 2022
CompletionActual
Nov 9, 2022
Results first posted
Mar 29, 2024
Last update
Mar 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03496766
Lead sponsor
Spanish Lung Cancer Group
Responsible party
Sponsor
First posted
Apr 12, 2018
Start date
May 7, 2018
Primary completion
Oct 30, 2022
Completion
Nov 9, 2022
Results posted
Mar 29, 2024
Last update
Mar 5, 2025

Study contacts

Luis Paz Ares, MD
study chair · Hospital 12 de Octubre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Tipifarnib

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